Total 729 quality manager job vacancies in Quality Assurance / Control category in Hong Kong

Roles & Responsibilities

• Arrange and conducts material and installation inspection
• Prepares the project quality plan and inspection and test plan
• Prepares material submittals for Client’s approval
• Assists the project manager on the method of statement preparation
• Oversee the overall on-site quality aspect of the project and ensure that the project team adheres to the requirement stipulated in the approved Project Quality Plan (PQP)
• Manage quality documentation such as certificates, test results and non-conformance reports are properly maintained and controlled
• Collaborate with the site team to resolve problems and prevent future defects
• Review of project specification ensuring the material proposed are complying to the specification
• Report any non-conformance (NC) and issue corrective actions (CAR)
• Prepares response for any non-conformities issued
• Arrange and conducts handing over inspection with the Main Contractor after completion of the work

Job Requirements:

• Diploma or Bachelor’s Degree in Civil Engineering / Architecture
• Minimum 5 years of local QA/QC experience in civil/architectural works
• Strong knowledge in QA/QC tools and procedures
• Knowledge in ISO 9001
• With leadership, strong documentation, communication and organisation skills
• Knowledgeable in local authority requirement
• Fluent in English with excellent interpersonal skills

Are you passionate about ensuring the highest standards of quality and regulatory compliance in a dynamic environment? Do you excel at building strong supplier relationships and driving continuous improvement? If so, we have an exciting opportunity for you to join our team as a Lead Supplier Quality Auditor, based in Singapore. 

This is your chance to contribute to impactful work in the medical device industry, where your expertise will directly support our mission of improving lives through innovation and quality.

As Lead Supplier Quality Auditor, you will be an integral part of our dynamic team. You will directly contribute to the success of our supplier auditing program by conducting audits to ensure suppliers meet strict regulatory and quality standards. Your work will play a vital role in maintaining the integrity and compliance of our supply chain.

What to Expect:

Conduct Supplier Audits: Execute audits across APAC (focusing on technical processes) to suppliers as part of the audit program, ensuring compliance with applicable standards, regulations, and Hologic specifications. Review production processes to identify improvement opportunities.

Supplier Action Plan Management: Manage and follow up on supplier action plans (SACAs) resulting from audits and assessments.

Issue Escalation: Notify and escalate any potential supplier quality or regulatory issues to the Supplier Quality Auditing Manager that could impact product quality or compliance.

Cross-Functional Collaboration: Work with other Supplier Quality Auditors/Engineers and cross-functional teams to troubleshoot and resolve supplier quality issues. Identify Subject Matter Experts (SMEs) for audit teams as needed.

Reporting: Participate in reporting supplier quality Key Performance Indicators (KPIs).

Audit Documentation: Ensure supplier audit file records are accurate, up-to-date, and properly maintained.

Audit Scheduling: Participate on the development and maintenance of the annual audit/assessment program schedule using a risk-based approach, including assessing controls and determining appropriate audit frequency.

Technical Expertise: Apply advanced knowledge of technical processes, materials control, and manufacturing processes to drive supplier quality improvements.

What We Expect:

Qualifications & Knowledge:

• Education: Bachelor’s degree in Engineering (Biochemical, Chemical, or related field). An ASQ Supplier Quality Engineer Certificate is a plus.
• Quality Auditor, with an accreditation record Certifications. Required accreditation from one of the following: ASQ (American Society for Quality) CQA (Certified Quality Auditor) or CBA (Certified Biomedical Auditor), IRCA (International Register of Certificated Auditors) Lead Auditor Registration, RABQSA Lead Auditor Certification or equivalent government body certification.
• Experience with master validation plans, protocols, and reports (IQ, OQ, PQ) and risk management (pFMEAs) process and documentation
• Industry Experience: 8+ years’ experience in medical device manufacturing or a related industry, with 5+ years in a Quality Auditing function preferred.
• Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485 (Required).
• Strong Communicator: Ability to effectively communicate at all levels of the organisation, both written and verbal.
• Analytical Mindset: Skilled at analyzing data, evaluating factors, and translating insights into actionable plans.
• Self-Motivated: Able to work independently with minimal supervision, while managing multiple complex projects.

Why Hologic?

• Work on impactful projects that make a difference in the medical device industry.
• Build relationships with suppliers around the globe, develop your skills and grow your career in a supportive and collaborative environment.

Travel Requirements: 50 - 60%
Language Requirements: Proficient in English (written and oral). A second language is a plus.

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality System

1. Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP

2. Monitor regulatory changes and update the QMS accordingly

3. Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)

4. Analyze quality data and metrics to identify trends and areas for improvement

5. Collaborate with cross functional teams to ensure that the quality standards are integrated into processes

Management Representative

1. Reports on QMS performance to top management and recommend improvement

2. Point of contact for certification bodies

3. Lead Management Review and follow up action items

Product Quality Management

1. Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound specified failures

2. Operational Quality Support. To facilitate continuous improvement initiatives, by providing on the floor support through use of quality tools and coaching teams to build ownership and proactive engagement with quality processes.

Customer Complaints Management

1. CCAR Manager. Manage the customer complaints handling process to ensure that all complaints are logged with right information for investigation till auditing process

2. Collaborate with cross functional team during the investigation, resolution and communication of customer complaints

3. Review interim CCAR reports to ensure that root cause is data driven and corrective action(s) address the root cause

Supplier Complaints Management

1. SCAR Manager. Approve SCAR – Supplier related complaints and defects, review and monitor the effectiveness of corrective actions

2. Collaborate with Procurement, Supplier and internal stakeholders to investigate issues and resolution

3. Collaborate with Procurement, Operation and Technology to assess risk and quality impact of raw material on finished goods

Global Quality Team Collaboration

1. Support the implementation of global quality initiatives, systems and tools

2. Ensure that local QMS aligns with global practices and corporate policies

3. Share best practices and lessons learned across global sites

Support Quality Contracts/Documentation

1. Review customer documents and quality related agreements for compliances to ensure clauses are relevant, assess the risks.

2. Response to customer request for certifications, compliance/quality related/audit documents

System

1. Conduct training for staff in Quality Procedure, Standards and Tools.

2. Lead processes identified by the Global Quality Team such as PPAP, QIR, CCAR, SCAR and Mastercontrol for the Asia Region

Requirements:

· Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

. Have knowledge of chemical production process in manufacturing environment

· Certificate in Quality Engineering is preferred. 6 Sigma certified will be at advantage

· 2-6 years of quality management experience.

· Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

· Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing.

· Good experience into customer & supplier audit and able to conduct training

· Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

· Occasionally overseas travel and weekly conference call is required for the role

· This position required to communicate closely with vendors and counter part in China.

Working hours:

Mon to Fri 8.30am - 5.30pm ( 1 day hybrid )

Job Description

1) Monitor and drive Quality performance (KPI) to meet company goal towards zero defect.

2) Ensure compliance to company and customer Quality requirements.

3) Engage and drive timely and effective failure/root-cause analysis (CAPA/8D) so as to prevent reoccurrence.

4) Develop and implement various quality, analytical, troubleshooting and risk analysis tools including FAI, 8D, CAPA, FMEA, Control Plan, Change Control, NPI.

5) Lead MRB review and disposition of non-conforming materials Communicate material.

6) Performing regular quality control process audits to ensure compliance with company and customer requirements.

7) Generate regular Quality reports, issue trackers and minutes.

8) Drive continuous improvement culture.

9) Support to customers with regarding to providing Quality support.

10) Develop or update Quality documentation to ensure they are up-to-date.

11) Any other matter required by the Quality Manager.

This role reporting to QA & H&S Manager, support daily production through final quality checks, SIRIM documentation, and coordination with machine operators in compliance with SOPs.

Role Responsibilities

· Conduct quality checks on final products produced from the machine to ensure compliance with quality standards.

· Complete and maintain all machine records as required by SIRIM and internal quality procedures.

· Prepare and submit daily product samples for quality inspection.

· Collaborate with team members and machine operators to ensure product quality is consistently maintained.

· Report any defects, abnormalities, or quality issues to the supervisor immediately.

· Ensure compliance with safety, hygiene, and production SOPs at all times.

· Support ongoing improvements in production and quality processes when required.

Requirements

· Certificate in Manufacturing/Quality/Engineering or related field is an advantage

· Preferably with experience in quality control, production, or manufacturing environment

· Ability to understand and follow SOPs, quality standards, and documentation requirements (e.g., SIRIM).

· Good communication skills and ability to work well with operators and team members.

· Detail-oriented, responsible, and able to identify quality issues accurately.

· Basic computer skills for data entry and record-keeping.

· Willing to work in a production floor environment and perform routine checks

Working hours:

12 hrs shift 8am-8pm / 8pm - 8am

1 day rest

SUMMARY

Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

· Develop and maintain QA plans and process routings, which reflect intended/actual activities.

· Provide support for all quoting activities by participation in initial process design, development, and implementation phases.

· Evaluate and support inspection processes via inspection aids and instruction guidelines.

· Support all training programs by development and implementation of specialized training sessions for all applicable functions.

· Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.

· Review all supplier or customer discrepancies. Coordinate and track the corrective/preventative action effort.

· Provide trend analysis of defects occurring at the customer, supplier and internally.

· Participate in the vendor survey activities as applicable.

· Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.

· Interface with all departments as applied to the Policies and Procedures with special regard to ISO, EN4600 and GMP documentation.

· Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.

· Interface and provide technical support on quality issues with the customer as needed.

· Support and focus corrective action efforts and utilizing the SPC data and corrective action tracking package and create and implement any meetings, procedures, or team-building concepts as necessary as part of the corrective/preventative effort.

· Serve as liaison between Jabil Circuit and suppliers or customers on quality related issues.

· Improve technical support for the quality organization.

· Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.

· Comply and follow all procedures within the company security policy.

MINIMUM REQUIREMENTS

Bachelor's degree required and two years related experience; or equivalent combination of education and experience.

Experience in SMT/PCBA background.

Experience in Supplier Quality Management

Experience in Incoming Quality operation.

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality System

1. Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP

2. Monitor regulatory changes and update the QMS accordingly

3. Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)

4. Analyze quality data and metrics to identify trends and areas for improvement

5. Collaborate with cross functional teams to ensure that the quality standards are integrated into processes

Management Representative

1. Reports on QMS performance to top management and recommend improvement

2. Point of contact for certification bodies

3. Lead Management Review and follow up action items

Product Quality Management

1. Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound specified failures

2. Operational Quality Support. To facilitate continuous improvement initiatives, by providing on the floor support through use of quality tools and coaching teams to build ownership and proactive engagement with quality processes.

Customer Complaints Management

1. CCAR Manager. Manage the customer complaints handling process to ensure that all complaints are logged with right information for investigation till auditing process

2. Collaborate with cross functional team during the investigation, resolution and communication of customer complaints

3. Review interim CCAR reports to ensure that root cause is data driven and corrective action(s) address the root cause

Supplier Complaints Management

1. SCAR Manager. Approve SCAR – Supplier related complaints and defects, review and monitor the effectiveness of corrective actions

2. Collaborate with Procurement, Supplier and internal stakeholders to investigate issues and resolution

3. Collaborate with Procurement, Operation and Technology to assess risk and quality impact of raw material on finished goods

Global Quality Team Collaboration

1. Support the implementation of global quality initiatives, systems and tools

2. Ensure that local QMS aligns with global practices and corporate policies

3. Share best practices and lessons learned across global sites

Support Quality Contracts/Documentation

1. Review customer documents and quality related agreements for compliances to ensure clauses are relevant, assess the risks.

2. Response to customer request for certifications, compliance/quality related/audit documents

System

1. Conduct training for staff in Quality Procedure, Standards and Tools.

2. Lead processes identified by the Global Quality Team such as PPAP, QIR, CCAR, SCAR and Mastercontrol for the Asia Region

Requirements:

· Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

· Certificate in Quality Engineering is preferred.

· 4-6 years of quality management experience. Junior with 1-2 experience in related field can also apply

· Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

· Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing.

· Good experience into customer & supplier audit and able to conduct training

· Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

· Occasionally overseas travel and weekly conference call is required for the role

· This position required to communicate closely with vendors in China.

Working hours:

Mon to Fri 8.30am - 5.30pm ( 1 day hybrid )

We are looking for an experienced Quality Assurance (QA) Manager – (Asset Servicing). In this role, you will manage critical quality engineering practice and governance standard.

Key Responsibilities:

• Promotes quality engineering principles through the adoption of standardized tools, templates, governance, and best practices.
• Defines, documents, and agrees on the test strategy, approach, plans, and required artifacts for projects or releases.
• Actively manages and coordinates testing activities to align with project or release timelines.
• Identifies, documents, and communicates testing risks, issues, and assumptions, proactively addressing stakeholder concerns and driving resolutions.
• Provides clear reporting, metrics, and assessments of test resources to senior stakeholders to support decision-making.
• Builds collaborative relationships with internal and external stakeholders, supports team well-being, and develops succession plans to manage key person dependencies.

Qualifications:

• Bachelor’s degree in computer science or related fields.
• Possesses strong knowledge of testing lifecycles and expertise in various testing types such as functional, integration, user acceptance, and model office testing.
• Experienced in different testing methodologies including Agile, Hybrid, and Waterfall, with proficiency in test management tools like JIRA, ALM, and Zephyr.
• Demonstrates over five years of leadership and management of test teams across multiple complex projects.
• Skilled in prioritizing demands, interpreting complex requirements, and communicating effectively with stakeholders and global teams.
• Has experience in the financial services sector, particularly in securities services or asset management.

Interested candidates may apply through the application system or send it to sg-rscontracting@morganmckinley.com. Shortlisted candidates will be notified.

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to Morgan Mckinley Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.morganmckinley.com/sg/privacy-policy. You acknowledge that you have read, understood, and agree with the Privacy Policy.

Morgan McKinley Pte Ltd
Koh Boon Sien
EA Licence No: 11C5502
EA Registration No. R1110345

We are seeking a Financial Crime Compliance Officer (FC CO) for Singapore. You shall be responsible for the Company’s ML/TF/PF compliance and oversight of financial crime-related areas (e.g., fraud, bribery and corruption, etc.). This includes developing policies, monitoring transactions, training staff, and reporting to regulatory bodies. Your role will report into the Money Laundering Reporting Officer (“MLRO”) Singapore. 

You will act as the primary advisor on AML/CFT matters, and shall also serve as the primary contact for regulators, when required, and ensure the company's adherence to anti-money laundering and counter-terrorist financing (AML/CFT) laws in alignment with MAS (Monetary Authority of Singapore) requirements.

Your Mission & Key Responsibilities:

• Provide logical, persuasive, and data-driven arguments to functional teams, fairly representing the  financial crime risk analysis for any particular application or business initiative.
• Monitor and analyze financial crime trends and regulatory changes to proactively adjust internal controls and procedures.
• Ensure the Fincrime space meets regulatory obligations and mitigates key financial crime risks across various products.
• Serve as the primary contact and liaison with regulatory bodies and law enforcement agencies on all financial crime matters.
• Monitor adherence to internal controls and regulatory enactments related to AML/CTF/PF and fraud.
• Act as a bridge and liaison between operational teams, FinCrime/Regulatory Product Compliance teams, regional compliance teams, and Compliance Oversight.
• Support product and product compliance teams with compliance insights by conducting thorough Financial Crime Risk Assessments for new products, services, and operational changes, proposing effective mitigation strategies.
• Propose and lead projects to enhance controls through training, process improvements, or product enhancements.
• Proactively identify gaps and lead remediation plans for any missing controls to mitigate financial crime.
• Support audits by closely cooperating with the audit team, preparing for audits, and managing follow-ups and remediation plans based on audit reports.
• Mentor and/or lead relevant team members and stakeholders in developing financial crime compliance expertise.
• Manage any regulatory requests / reporting end-to-end, ensuring timely, accurate, and complete submissions that meet all regulatory requirements.
• Manage regular and ad-hoc fincrime reporting to the MAS accurately and within prescribed deadlines.
• Handle escalations from the SPF/MAS/CAD or any external stakeholders, promptly disseminating information to relevant internal teams for timely resolution and official response.
• Maintain and update relevant manuals/policies

Support Compliance Office

• Assist the local MLRO with regulatory horizon scanning, tracking, and managing both internal and external projects to ensure alignment with evolving regulations, particularly those in the fincrime space.
• Collaborate with the MLRO, Compliance Officer and other internal stakeholders  to draft and update policies, ensuring compliance with local regulation and effective policy implementation.
• Monitor compliance risks and KPIs, coordinate periodic governance and stakeholder review meetings, maintain robust compliance frameworks and documentation, and support liaison efforts during audits (internal, external, and regulatory).
• Help maintain robust compliance frameworks and documentation.
• Support and facilitate liaison efforts during internal, external, and regulatory audits/examinations.

Projects and compliance specific reviews:

Depending on the overall compliance program and criticality, engage in and manage specific and thematic compliance reviews to assess control effectiveness and identify potential gaps.

Qualifications

• 8- 10 years of experience in regulatory and / or fincrime compliance 
• Compliance Expertise: Strong background in compliance, law, accounting, or consulting, with specialized expertise in AML/CTF/PF  practices.
• Financial Crime Knowledge: Comprehensive understanding of financial crime regimes and their practical application within the organization's operations.
• Analytical Skills: Proven ability to analyze transactions, identify risks, and critically evaluate compliance processes.
• Leadership and Influence: Demonstrated ability to lead and motivate teams, cultivate strong professional relationships, and drive effective change.
• Communication Prowess: Excellent written and verbal communication skills for articulating findings clearly and engaging effectively with senior management and regulatory bodies.
• Risk Management Experience: Extensive experience in conducting thorough risk assessments and accurately interpreting identified risks.
• Organizational Skills: Strong time and project management capabilities.
• Domain Familiarity: Sufficient familiarity with operational and product domains to effectively frame problems and propose solutions.
• Professional Experience: At least 8 years of experience as assisting the Money Laundering Reporting Officer (MLRO) or Head of Fincrime or in the Compliance team.
• Certifications (Optional): ICA/ACAMS certification is considered a valuable asset.

Industry: Freight Forwarding / Logistics

MNC Environment

Permanent role (AWS Guaranteed + Variable Bonus + Overtime)

Responsibilities:

• Inspect aircraft spares to ensure quality and complianceVerify aircraft spares with appropriate documentation from OEMs, vendors, and suppliers
• Contribute to continuous improvement projects to enhance work areas and procedures
• Facilitate periodic audits conducted by civil aviation authorities and customers
• Maintain shelf-life records for aircraft spares with limited service life
• Monitor and conduct surveillance audits on all activities within the Bonded Stores
• Raise Discrepancy Reports for any issues identified with aircraft spares in the Bonded Stores

Requirements:

• Work experience in the aviation industry would be an advantage
• Excellent interpersonal & influencing skills
• Proficient in Microsoft Office & presentation skills

Job ID: QX96WW7Y

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

Kindly email your resume in a detailed Word format to carlo@peopleprofilers.com

We regret that only shortlisted candidates will be notified

People Profilers Pte Ltd

20 Cecil Street, #08-09 PLUS Building Singapore 049705

+65 6950 9747

EA Licence Number: 02C4944

Registration Number: R1100011

EA Personnel: Carlo Antonio Dela Cruz

Job Description

• Oversee overall quality and safety of food products at Central Kitchen
• Ensure that food products meet standards set by company and regulatory bodies
• Develop and review quality and safety policies
• Conduct and manage regular inspections and audits
• To maintain and improve existing quality control procedures
• Conduct investigations on customers’ feedback
• Validate that all products were made in compliance with established QA protocol
• Ensure that standard operating procedures are adhered to
• Monitor quality standards of products
• Ensure that all activities conform to HACCP & AVA/NEA guidelines
• Supervise and oversee all quality assurance matters
• Product and process development
• Assist in all areas of R&D, product and process development, food tasting

Job Requirements

• Minimum Degree in Food Science & Technology or related field
• Preferably 5 years of working experience in the QA field (inspection, central kitchen or manufacturing background) in the F&B industry
• Able to write and converse well in both English & Mandarin due to operational needs to communicate with mandarin-speaking clients
• Highly motivated, meticulous and takes initiative

To submit your application, please apply online apply@rn-care.com or call +(65) 6514 9838 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Responsibilities:

• Conduct sampling and perform routine/non-routine microbial & chemical analyses such as purified water, raw materials, bulk products, finished products, and stability samples in accordance with approved procedures.
• Prepare laboratory reagents, microbiological culture media, media agar plates, sterilization of apparatus, and decontamination of microbiological waste.
• Carry out environmental monitoring activities (viable and non-viable airborne particulate contamination monitoring and microbial swab test).
• Assist in Microbial Limit Test (MLT), Antimicrobial Efficacy Testing (AET), Growth Promotion Test (GPT), Gram staining, microscopy, and microbe identification testing in accordance with established international standards.
• Assist in purified water system performance verification, production cleaning, sanitization validation, new product introduction, and continuous improvement initiatives.
• Document all results in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Participate in out-of-specification and deviation investigations and recommend corrective actions.
• Maintains a high level of good housekeeping including ensuring all glassware, apparatus, and testing equipment are cleaned promptly once the analysis is complete.
• Participate in internal assessment and audit as required.
• Any other duties and responsibilities as assigned by the supervisor.

Requirements:

• Diploma in Microbiology, Biochemistry, or related discipline.
• Minimum 2 years of experience in cosmetics, food, nutritional personal care, medical devices, or pharmaceutical quality control laboratory.
• Knowledge of Good Manufacturing Practices or Good Laboratory Practices.
• Candidates with exposure to Halal, ISO 17025, or ISO 22716 will be an added advantage.
• Fluent in both oral and written English.
• Good communication and interpersonal skills.
• Systematic and able to work under pressure.
• Mature, proactive, attention to detail, well organized, analytical thinking, and quality minded.
• Meticulous and able to follow through with tasks promptly.
• Able to work independently as well as in a team.

Senior Quality Validation Specialist
(6 month contract)

About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission

The essential functions include but are not limited to:

• The incumbent will be part of Digital & Data Quality (DDQ) team for Operational Support, Lifecycle Management (LCM), and Capital projects, collectively known as Projects thereafter, will be responsible for the quality aspects of Good Manufacturing Practice (GMP) computerized systems/equipment and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
• This includes involvement in all quality-related activities for computerized systems which are required by the client Manufacturing site Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• The incumbent must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Primary Responsibilities:

As part of the DDQ team and reporting to the Associate Director of DDQ or higher, the incumbent will be responsible for:

• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes. This includes:
• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Interfacing with the Manufacturing site DMO (Digital Manufacturing Organization) and other internal & external entities to align GMP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives
• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
• Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.

Requirements:

• Diploma or bachelor’s degree in chemical engineering or any other relevant engineering field
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations in GMP environment.
• At least 5 years of experience in regulated pharmaceutical manufacturing industry.
• At least 3 years of experience in delivering validated Lab Systems Qualification experiences solutions or an application support role in a regulated environment.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.

Reg No: R22104540
EA License no: 94C3609

Overview

• To promote an effective quality programme including identifying, coordinating and participating with relevant departments on quality and patient safety training needs, standards development, design and implementation of audit tools and risk management activities:
• Keep abreast of appropriate regulatory agency requirements related to quality assurance, patient safety standards and other relevant regulatory requirements (e.g., Personal Data Protection Act and Health Information Bill/ Act);
• To initiate continuous service improvements through constant monitoring, audits and training.

Responsibilities

• Manage incidents, customer feedback/ complaints and provide timely responses and effective preventive measures
• Identify and develop strategies to mitigate risks, improve clinical quality and patient safety. Measure and evaluate data to determine the ultimate impact of the programs and initiatives
• Work with consultants and internal customers to achieve and maintain certifications
• Operationalization of Health Information Bill/ Health Information Act
• Collaborate with cross-functional teams to analyze and optimize healthcare processes, workflows, and procedures
• Maintain statistics on Quality Indicators e.g., Productivity, Customer Service Survey Data (including incidents, feedback, compliments, complaints). Prepare documents for management reporting as required
• Assist to develop, implement and review policies and procedures relating to quality management functions for standardisation and compliance to quality and regulatory standard
• Maintain an inventory of all documents within the organisation as document controller
• Maintain external correspondences including MOH/ AIC/ MOM, ensure all correspondences are tracked
• Identify and assess potential risks to patient safety and quality of care
• Any other tasks as assigned by the Manager/ CEO

Interested candidates, please forward your resume to kevynhuang@recruitexpress.com.sg

Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)

• Role: Test Manager – Data Domain
• Job Requisition Number: TIS-001
• Job Level: 10-12 years of relevant experience (L4)
• Location: Singapore

Responsibilities

• Lead the understanding and interpretation of project delivery requirements from a testing perspective to ensure alignment with business goals.
• Manage and oversee daily delivery of test services provided by Bank-appointed vendors, ensuring quality and timeliness.
• Design detailed test cases from test scenarios using functional knowledge of the Financial Service Data Model (FSDL) domain to validate data integrity and processes.
• Collaborate with test service providers and bank stakeholders to plan and coordinate all testing-related activities for programs or projects.
• Communicate scope changes promptly to test service providers and adjust plans to mitigate impact on testing schedules and deliverables.
• Serve as the primary escalation point for issues raised by bank stakeholders regarding testing service providers, facilitating timely resolution.
• Quantify, track, and report test statuses, service level agreements (SLAs), and key performance indicators (KPIs) to ensure testing transformation targets are met.
• Participate in forums to contribute ideas and drive innovation in testing transformation initiatives.
• Establish and maintain effective working relationships with Vendor Test Managers and Test Leads across relevant domains to foster collaboration and knowledge sharing.

Required competencies and certifications

• 10-12 years of experience in test management activities.
• 8-10 years of experience in Banking with expertise in Financial Service Data Model (FSDL).
• 5+ years of experience with Teradata, Data Warehouse, ETL processes, and SQL.
• Experience with QuerySurge automated testing tools or equivalent automation skills.

Preferred competencies and qualifications

• 8-9 years of experience in Data Migration testing projects for cloud or on-premise databases.
• Ability to work independently with clients, demonstrating proactivity and self-management.
• Skills in soliciting and eliciting client needs and requirements.
• Knowledge of project management and software development methodologies.
• Industry experience in the banking domain is advantageous.
• Familiarity with programming languages and SQL to support defect triaging and automation efforts.
• Exposure to scripting languages used in test automation.