Total 105 procurement specialist job vacancies in Quality Assurance / Control category

This role is responsible to drive compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Responsibilities:

1. Quality Policies & Procedures:

Determine, implement & promote policies and procedures for Company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others

2. Quality Assessment & Standards:

Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry

3. Compliance & Quality Program Management:

Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management:

Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System:

Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs:

Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits

7. Certification Audits:

Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.

8. Operations & Customer Audit Programs:

Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison:

Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback:

Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs:

Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems

Requirements :

• Hold local pharmacist license

• Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role

• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

• Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.

• IATA CEIV will be desired but not necessary.

• Familiar with drugs control and secondary labelling system

• Experience in conducting external and internal audits

• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Working hours:

Mon to Fri 9am-6pm

Key Responsibilities

• Conduct Customer Due Diligence (CDD) and Enhanced Due Diligence (EDD) reviews for new client onboarding, periodic reviews, and trigger-event reviews involvinghigh-risk individual and corporate clients, including Trusts, Funds, VCCs, SWIFT RMA, and Correspondent Banking relationships.
• Review client documentation to ensure compliance with AML/CFT regulations, sanctions requirements, FATCA, CRS, and the Bank's internal KYC policies and procedures.
• Identify potential AML/CFT risks, suspicious activities, and unusual transaction patterns, and escalate findings in accordance with regulatory and internal requirements.
• Provide KYC/CDD advisory support to Business Units and collaborate with stakeholders to resolve due diligence and compliance-related matters.
• Prepare and maintain AML/KYC reports, review trackers, management reports, and compliance records.
• Support audits, regulatory reviews, and compliance reporting by providing documentation, data, and analysis as required.
• Conduct KYC/CDD awareness sessions and stay updated on regulatory developments, financial crime typologies, and industry best practices.
• Contribute to process improvements and support ongoing AML/KYC and compliance initiatives.

Requirements

• Minimum 3–5 years of experience within financial services, including at least 2 years of AML/KYC/CDD compliance experience.
• Strong experience handling high-risk and complex client structures, including corporate entities, Trusts, Funds, VCCs, Correspondent Banking, and SWIFT RMA reviews.
• Good understanding of MAS Notice 626, AML/CFT regulations, sanctions compliance, and FATCA/CRS requirements.
• Strong analytical, investigative, and report-writing skills with high attention to detail.
• Good communication and stakeholder management skills with the ability to work independently in a fast-paced environment.
• ACAMS or ICA certification is advantageous.

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd   |   EA Licence:11C3793   |   Nurul Amirah |   Registration No: R22108940

Industry: Logistics / Hi-Tech

Conducive Working Environment

Location: East

Responsibilities:

• Conduct regular meetings with workcentre to validate and follow up on manufacturing issues that is related to logistics
• Provide logistics input to identify the cause of the defects through warehouse validation with the support of QC inspectors and work with appropriate process owners to address the issues through periodic (weekly/ daily) meeting
• Drive reported logistics issues for proper containments, correction and preventive actions
• Handle workcentre complaints and tasks; and perform root-cause analysis to identify and propose effective correction and process improvements
• Process audit lead for site focal and perform quarterly process audit and report out findings closure on monthly, and quarterly basis
• Draft and prepare quality instructions, guidance, stand down for quality
• Site quality focal for first line quality matters in logistics that supports customer manufacturing activities
• Prepare reports on weekly, monthly, and quarterly basis for logistics review with customer
• Conduct visual inspection and report any non-conformity / exception from shipment
• Support management to achieve required KPI
• Participate in process improvement initiatives and implementation
• Continuously striving for higher level of performance efficiency

Requirements:

• Experience with implementation of 8D, CAPA (Corrective and Preventive Action) programs
• Certifications advantage including but not limiting to Six Sigma, Internal Auditor, etc.
• Quality inspection and auditing experience
• Knowledge of tools, concepts, and methodologies of quality associate
• Industry specified experience in manufacturing preferred
• Knowledge of relevant regulatory requirements such as ISO9001:2015, GDPMDS, etc.

Job ID: JOB-00442

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 69509747   

EA License Number: 02C4944

Registration Number: R1100011

EA Personnel: Carlo Antonio Dela Cruz

THE OPPORTUNITY

• Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide!
• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across

WHAT YOU WILL DO:

Batch Review/Batch Disposition

• Reviews and closes batch record
• Collaborates with Operations team to improve the batch record errors which includes trending analysis
• Performs batch disposition in SAP system and issues related batch disposition documentation
• Communicates to Qualified Person/Qualified Release Personnel on any information that may result in revoking of released status of any shipped material
• Discussion with Qualified Person/Qualified Release Personnel periodically related to batch disposition
• Provides Batch Review/Batch Disposition related training and serve as subject matter expert (SME) for batch review in the respective area
• Act as coordinator with IPT & SCM for review and release.

Deviation/OOS/Customer Complaints

• Participates in investigations, reviews and approves investigation reports.
• Tracks Corrective Actions/Preventive Actions and ensures timely completion.
• Generates deviation summary reports.
• Performs trend analysis of root causes on a periodic basis.
• Reviews and closes completed OOS.

Change Control

•  Reviews and approves change control request, qualification activities from quality perspective.
• Acts as Quality representative in change control meetings.
• Reviews change control (ACC, ECC, PCR).

Others

• Reviews and approves batch-sheet (new and changes).
• Reviews and approves SOPs, Forms, and procedures.
• Reviews and approves cleaning protocol, cleaning reports, and cleaning records.
• Collaborates with other functional department in each plant to develop action plans for identified audit issues, identify the non-compliance issues and proactively collaborate with the relevant department to resolve issue.
• Work closely with other functional groups to raise the level of awareness towards cGMP, company policies and procedure, regulatory guide and codes
• Participate in continuous improvement initiative as part of the MPS culture in the company in Singapore.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Perform any other tasks as assigned by manager.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor's degree in science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
• Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
• Strong preference for previous quality / compliance experience, and previous complaint experience. 
• Minimum of 1-3 years' experience within the pharmaceutical industry. 
• Requires ability to identify and implement continuous improvement initiative.
• Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements.  
• Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment. 

This is a career conversion program under Workforce Singapore (WSG) and candidates must meet the following criteria and are open to the following conditions:

• Singaporeans/Singapore PRs only
• PMETs/Mid-Careerist with no prior work experience in Biopharma industry are welcomed to apply
• Open to two years contract

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path 
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future

Senior Specialist, Quality Assurance (6-Month Contract)

Pharma MNC

islandwide pick up, Tuas area

Job Summary

The Senior Specialist, Quality Assurance will support day-to-day QA operations within a multi-product cGxP manufacturing environment. The role ensures compliance with approved SOPs, regulatory requirements, and internal quality standards.

This position provides QA oversight across quality systems, validation, compliance, audits, and manufacturing operations, while driving continuous improvement, data integrity, and inspection readiness initiatives.

Key Responsibilities

• Support daily QA operations in accordance with approved SOPs, policies, and cGxP requirements within a multi-product manufacturing environment
• Review and approve SOPs, protocols, reports, batch records, logbooks, deviations, CAPA, change controls, and other quality documentation
• Provide QA oversight for manufacturing, validation, engineering, laboratory, and operational activities to ensure GMP and GDocP compliance
• Lead and support deviation investigations, root cause analysis, CAPA implementation, and change management, ensuring timely closure and effectiveness
• Identify and assess operational and compliance risks, and recommend corrective and preventive actions or process improvements
• Support regulatory inspections, customer audits, and internal audits, including audit readiness and response coordination
• Perform batch record review, lot genealogy compilation, product disposition support, and release activities where applicable
• Ensure compliance with data integrity principles aligned with regulatory and company expectations
• Collaborate cross-functionally with Manufacturing, Engineering, Validation, QC, and Supply Chain teams to support quality and operational objectives
• Lead or support continuous improvement initiatives and coordinate cross-functional deliverables
• Conduct QA on-the-floor activities, walkdowns, and shopfloor oversight to ensure compliance and operational excellence
• Serve as a Subject Matter Expert (SME) or Qualified Trainer where applicable

Interested candidates, do submit your resume to : jocelynchan@recruitexpress.com.sg OR telegram @jocelynchan

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1331820

• Salary up to $6,000
• 5 days work week
• Jurong East MRT

Our client is an emerging MNC with a global presence — headquartered in Singapore, with R&D and technical operations across Asia and customers in worldwide data-centre and high-speed optical markets.

SOX 404 Compliance & Implementation

• Lead the design, documentation, and implementation of SOX 404-compliant internal controls over financial reporting (ICFR)

• Develop comprehensive process documentation, including risk control matrices (RCMs), flowcharts, and control descriptions

• Execute management's assessment of internal control effectiveness in accordance with SEC and PCAOB requirements

• Coordinate external auditor SOX 404 testing and manage remediation of identified deficiencies

IPO Readiness Support

• Support the Company's U.S. listing preparation by ensuring timely establishment of IPO-ready internal control environment

• Align internal control framework with U.S. GAAP, SEC regulations, and PCAOB auditing standards

• Collaborate with legal, finance, and business teams to address control gaps identified during IPO readiness assessments

• Prepare SOX-related disclosures for registration statements and periodic SEC filings

Risk Assessment & Control Optimization

• Conduct annual fraud risk assessments and entity-level control evaluations

• Identify key financial reporting risks and design preventive and detective controls

• Monitor control operating effectiveness through ongoing testing and continuous auditing techniques

• Drive automation of controls and implementation of data analytics for control monitoring

Cross-functional Collaboration

• Partner with process owners across business units to embed control consciousness into daily operations

• Provide SOX 404 training and guidance to finance and operational teams

• Serve as primary contact for external auditors on ICFR matters

Requirements

• Bachelor's degree or above in Accounting, Finance, or a related field, with CPA, CIA, or CISA certification preferred.

• Minimum 4 years of experience in internal control, internal audit, or external audit, preferably with a Big 4 background.

• Hands-on experience with SOX 404 compliance is essential, including involvement in first-year implementation or remediation projects. Prior direct experience in U.S. IPO or SEC reporting readiness is highly desirable.

• Strong technical proficiency in U.S. GAAP, PCAOB standards, and the COSO 2013 Framework, as well as practical experience with ERP systems such as SAP, Oracle, or NetSuite and data analytics tools.

• Industry-specific experience in semiconductor is preferred.
  
  R22107887 | Gladys Chang Si Min

Role Overview

This role is responsible for translating regulatory requirements into actionable AML/KYC compliance processes, providing subject matter expertise across audits, regulatory reviews, quality assurance, and remediation oversight. The ideal candidate brings deep technical knowledge of financial crime compliance and the ability to operate at both strategic and operational levels.

Key Responsibilities

1.  AML/KYC Regulatory Framework

• Interpret and translate applicable AML/KYC regulatory requirements (e.g., FATF recommendations, local financial intelligence unit directives, BSA/AML, MAS Notice, AMLA) into clearly defined internal policies, procedures, and process documentation.

• Conduct gap analyses between current operational practices and evolving regulatory expectations; develop remediation roadmaps with measurable milestones.

• Advise business lines and operations teams on the practical application of AML/KYC obligations, ensuring requirements are embedded in day-to-day workflows.

• Monitor legislative and regulatory developments and assess their impact on existing frameworks, escalating material changes to senior stakeholders.

2.  Audit & Regulatory Review Support

• Serve as the primary compliance point of contact for internal audit engagements, regulatory examinations, and external reviews related to AML/KYC.

• Coordinate end-to-end audit logistics, including document collation, interview preparation, walkthrough facilitation, and management response drafting.

• Liaise between internal stakeholders (operations, legal, technology, senior management) and external parties (regulators, external auditors) to ensure consistent and accurate information flow.

• Track and manage audit findings and regulatory observations through to closure, providing periodic status reporting to governance committees.

3.  Thematic Review & Quality Assurance

• Design and execute thematic reviews across AML/KYC programme components, including Customer Due Diligence (CDD), Enhanced Due Diligence (EDD), transaction monitoring, and Suspicious Activity Reporting (SAR).

• Develop QA frameworks, sampling methodologies, and testing scripts to assess the effectiveness and consistency of frontline compliance controls.

• Analyse QA findings to identify systemic issues, root causes, and trends; prepare actionable reports for management and relevant governance forums.

• Collaborate with process owners to implement corrective actions and validate their effectiveness through follow-up testing cycles.

4.  Scope of Work (SOW) Remediation Oversight

• Provide oversight and governance over remediation programmes arising from regulatory findings, internal audit observations, or management-initiated reviews.

• Define remediation scope, agree on deliverables and timelines with accountable owners, and track progress against agreed milestones.

• Challenge and validate the quality of remediation outputs, ensuring solutions address root causes rather than symptoms.

• Prepare concise and accurate management information packs for escalation to senior leadership and board-level risk committees as required.

5.  Training & Capability Building

• Develop and deliver AML/KYC training programmes tailored to distinct audiences — from frontline staff to senior management — ensuring content is current, engaging, and aligned with regulatory requirements.

• Identify training needs through QA outcomes, audit findings, and regulatory updates; maintain a training calendar and track completion rates.

• Evaluate training effectiveness through assessments and feedback mechanisms; continuously improve content based on results.

. Champion a culture of financial crime awareness by embedding AML/KYC principles into onboarding, periodic refreshers, and change management initiatives.

Qualifications & Experience

• Minimum 8 – 10 years of progressive experience in AML/KYC compliance within a financial institution, regulatory body, or Big 4 professional services environment.

• Deep working knowledge of global AML/CFT regulatory frameworks (FATF, BASEL, local jurisdictional requirements).

• Demonstrated experience leading or supporting regulatory examinations, internal audits, and compliance programme reviews.

• Proven ability to design and execute QA frameworks, thematic reviews, and control testing programmes.

• Strong project management skills with experience overseeing multi-workstream remediation programmes.

• Excellent written and verbal communication skills; able to present complex compliance topics clearly to senior and non-technical audiences.

• Relevant professional certifications are an advantage (e.g., CAMS, CGSS, ICA Diploma in AML, CFE).

This role supports supplier management programs, including performing quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements with suppliers.

Responsibilities:

• Perform supplier qualification activities such as liaising with stakeholders (manufacturing team, procurement team, QC etc.) and suppliers (manufacturers and distributors of supplies, outsourced service provider etc.) to ensure supplier questionnaires are completed with relevant documents (e.g. business license, ISO certificates etc.)
• Liaise with affiliate sites personnel for qualified supplier information deck to assess on the leverage of supplier qualification documents.
• Lead/Support on-site audit at supplier site (if necessary). Prepare audit agenda, audit report and coordinate with supplier for CAPA response to close of audit observations.
• Draft Quality Agreement (QAA) with new suppliers or review existing QAA for existing suppliers engaged by affiliate sites
• Perform quality assessment based on company procedures to determine if suppliers can be qualified for GMP use.
• Update qualified supplier list.
• Perform periodic performance monitoring, supplier change notification and decommissioning of supplier.
• Perform other tasks assigned by leadership.

About You:

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA.
• Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
• Experience in leading audits is preferred.
• Experience with biopharma commercial quality systems is preferred.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise etc.
• Strong learning ability.
• Effective at cross-functional communication and collaboration.

Contract Duration: 6 months
Office hours

Key Responsibilities:

• Maintain and continuously improve the Integrated Management System (IMS) in line with applicable standards, driving the implementation of ISO 9001, 14001, and 45001
• Ensure all IMS documentation is up to date, controlled, and properly implemented across the organization
• Coordinate both internal and external audits, including surveillance and certification audits
• Monitor corrective and preventive actions to ensure timely closure and continuous improvement.
• Maintain accurate EHS records, reports, and documentation.
• Conduct regular site inspections and safety audits while collaborating with stakeholders to ensure safe working practices.
• Monitor corrective and preventive actions to ensure timely closure and continuous improvement.

Job Requirements:

• Degree/Diploma in Environmental Health & Safety, Engineering, or a related field
• Min 4 years of EHS & quality experience in a chemical manufacturing environment
• Knowledge of ISO standards (9001, 14001, and 45001)
• Familiarity with local Singapore EHS regulations is an advantage
• Comfortable working at the west of Singapore (Tuas)
• Previous experience using SAP is preferred

how to apply

If you are interested in the position , kindly send your CVs to yitwei.kwan(@)randstad.com.sg

Please include your availability, expected salary and reason for leaving current job

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913

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

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

This role is responsible to drive compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Responsibilities:

1. Quality Policies & Procedures:

Determine, implement & promote policies and procedures for Company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others

2. Quality Assessment & Standards:

Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry

3. Compliance & Quality Program Management:

Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management:

Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System:

Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs:

Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits

7. Certification Audits:

Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.

8. Operations & Customer Audit Programs:

Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison:

Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback:

Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs:

Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems

Requirements :

• Hold local pharmacist license

• Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role

• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

• Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.

• IATA CEIV will be desired but not necessary.

• Familiar with drugs control and secondary labelling system

• Experience in conducting external and internal audits

• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Working hours:

Mon to Fri 9am-6pm

Position Summary

This role is responsible for ensuring the organisation’s adherence to all applicable regulatory and compliance requirements. The incumbent will act as a trusted compliance advisor to business units, working closely with stakeholders to embed regulatory compliance into business activities while supporting overall organisational objectives.

Key Responsibilities

• Keep abreast of regulatory developments and changes that may impact the organisation, and proactively advise business units on implications and required actions
• Ensure compliance with all relevant laws, rules, regulations, and internal policies, applying sound ethical judgment to business practices and conduct
• Provide practical guidance to business units on regulatory requirements arising from day-to-day operations and emerging business initiatives
• Partner closely with business units to identify, assess, and manage regulatory and compliance risks, including handling time‑critical incident reporting to regulators
• Assess regulatory and compliance risks associated with business decisions, with due consideration given to the organisation’s reputation and key stakeholders’ interests
• Develop, implement, and maintain compliance policies, standards, frameworks, and procedures in line with regulatory expectations
• Design, execute, and oversee compliance testing, continuous assurance activities, and reporting of compliance reviews
• Conduct compliance training and awareness programmes to enhance understanding of regulatory obligations and internal policies
• Manage regulatory inquiries, examinations, and information requests, and escalate significant compliance matters to senior management in a timely manner

Requirements

• Degree holder in Computer Science, Information Technology, Information Security, Economics, Accounting, or a related discipline
• Minimum of 7 years of compliance experience within a regulated financial or payments-related industry
• Strong analytical skills with a high level of attention to detail
• Excellent problem‑solving abilities, with the capacity to prioritise and manage multiple workstreams concurrently
• Proven team player with a strong track record of working effectively in collaborative environments
• Strong interpersonal, communication, and stakeholder management skills
• Demonstrated strength in documentation, policy drafting, and report writing
• Self‑driven and able to operate independently with minimal supervision

EA: 25C2690 | R1221146

Salary: up to $4000
Duration: 7 months

Working Days & Hours: Mon-Fri Office Hours

Location: Tuas (islandwide company pickup)

Job Description:

* Management of training records including processing and data entries of form

* Management of GMP document lifecycle in Documentation Management System including archiving and inactive records

* Management of documents within onsite archive room

* Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility

* Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience

* Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections

* Generally provide basic compliance support to staff in all departments

* Demonstrate appropriate interpersonal skills that encourage collaboration of

* individuals or teams to meet objectives

* Uphold data integrity principle in accordance to policies. Proactively evaluate, identify and improve data integrity process.

* Any other tasks as and when assigned by Supervisor

Job Requirements: Min Diploma/Degree in Life Sciences or similar w min relevant internship experience & QMS in pharmaceutical industry

Interested candidates, please submit your resume to: allylok@recruitexpress.com.sg

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

allylok@recruitexpress.com.sg