Total 275 Quality Assurance / Control job vacancies in Tuas

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

RESPONSIBILITY
Responsible for leading and managing the Quality Management System and overseeing QA operations within a manufacturing environment. Act as the Management Representative (QMR) and plays a key role in driving quality excellence, compliance, and continuous improvement across the organization.

Quality Management System (QMS) &Compliance

• Serve as Management Representative (QMR) for the ISO 9001 Quality Management System
• Ensure compliance with ISO 9001, customer specifications, and applicable regulatory requirements
• Drive continuous improvement of the QMS aligned with business objectives
• Oversee control, revision, and implementation of Quality Manuals, SOPs, work instructions, and records.
• Drive audit readiness culture across all departments

Audit & Certification Management

• Plan and lead internal audits to ensure compliance and effectiveness of QMS
• Manage external audits (ISO certification bodies, customers, regulatory audits)
• Ensure timely closure of audit findings and non-conformities
• Maintain proper audit documentation and compliance records

Manufacturing Quality Assurance & Process Control

• Establish and monitor in-process and final inspection standards
• Ensure raw materials, productions processes and finished goods meet defined specifications
• Collaborate with Production to improve process capability and reduce variation
• Implement Statistical Process Control (SPC) and quality tools

Supplier Quality Management

• Develop supplier qualification and performance evaluation programs
• Conduct supplier audits and performance reviews
• Work with Procurement to resolve supplier-related quality issues
• Define incoming quality control standards and acceptance criteria

Customer Quality & Complaint Handling

• Lead investigation of customer complaints, returns, and product non-conformance
• Perform root cause analysis (e.g. Fishbone, 5 Whys)
• Implement and monitor Corrective and Preventive Actions (CAPA)
• Interface directly with key customers on quality-related issues and audits
• Track customer satisfaction and implement improvement plans

Quality Data, Reporting & KPIs

• Establish and track quality KPIs (defect rates, scrap rates, customer complaints, supplier performance)
• Analyze trends and drive data-based improvements
• Prepare monthly and quarterly reports for management review
• Highlight risks, opportunities, and performance insights

Team Leadership & Capability Development

• Lead, coach, and develop QA/QC team members
• Manage manpower planning and resource allocation
• Identify skills gaps and implement training programs

Continuous Improvement & Operational Excellence

• Drive initiatives such as Lean Manufacturing, Six Sigma, and Kaizen
• Support digitalization and automation in quality processes

Cross-Functional & Stakeholder Management

• Collaborate with Production, Operations Service and Supply Chain on quality-related improvements
• Support new product development (NPI) by ensuring quality standards are defined and met\
• Act as liaison with certification bodies, auditors and customers
• Conduct and participate in management review meetings and strategic planning

REQUIREMENT

• Degree / Diploma in Engineering or related field
• Minimum3-5 years of experience in Quality Assurance within manufacturing
• Strong knowledge of ISO 9001 and audit processes
• Experience with quality tools (CAPA, etc.)
• Leadership and team management skills
• Strong analytical and problem-solving abilities

Company Overview

Assurance Technology Pte Ltd is a leading healthcare IT partner in Singapore, providing Clinic Assist software since 1995. We collaborate closely with clinicians to deliver robust, feature-rich healthcare solutions that enhance clinical workflows and patient care.

Job Summary

Support accounting and human resources functions by managing financial transactions, client communications, employee records, and HR processes to ensure operational efficiency and compliance.

Responsibilities

• Communicate with customers to resolve account-related inquiries and ensure accurate billing
• Prepare and issue customer invoices and follow up on overdue payments to maintain cash flow
• Create client quotations to support sales and service agreements
• Perform bank reconciliations and monitor bank transactions to ensure financial accuracy
• Accurately record all payments and receipts and submit financial records to external accountants
• Coordinate with external auditors and relevant agencies to facilitate audits and compliance
• Maintain employee records and documentation to support HR administration
• Prepare and issue offer letters and employment contracts to onboard new hires
• Manage onboarding and offboarding processes to ensure smooth employee transitions
• Handle work pass applications and renewals to comply with regulatory requirements
• Track employee attendance and leave records to support payroll and workforce management
• Provide timely payroll support to ensure accurate employee compensation
• Manage internal HR communications to keep staff informed and engaged
• Assist in organizing staff activities and welfare initiatives to promote workplace morale
• Perform other ad-hoc duties as assigned to support team and organizational needs

JobRequirements

• Diploma in Accounting, Human Resource Management, Business Administration, or related field
• Preferably with relevant experience in both HR and accounting roles
• Responsible, well-organised, and able to handle confidential information with integrity
• Strong communication and coordination skills
• Committed and proactive in managing assigned responsibilities

Responsibilities: 

• Handle customer quality claims; drive corrective & preventive actions and verify effectiveness.
• Lead or participate in MRB to ensure only conforming products are shipped.
• Maintain SAP/QM systems and manage Quality Notifications.
• Conduct quality trainings (QMS, FMEA, SPC) and implement quality tools (FMEA, QFD, SPC, Edit Notes).
• Prepare and report quality data, including process/product capability and Cpk monitoring.
• Ensure accuracy of CofC and compliance with customer requirements.
• Perform internal audits, support customer audits, and monitor quality performance.
• Contribute to continuous improvement initiatives and support documentation (procedures, training materials, SPC manuals).
• Perform ad-hoc assignments as needed.

Requirements:

• Degree in Engineering or B.Sc. in Physics/Chemistry.
• At least 2 years QA experience, including SPC and QA control in semiconductor environment.
• Strong statistical analysis skills and experience with statistical tools.
• Knowledge of quality tools: FMEA, SPC, DOE, PPAP, APQP, MSA.
• Basic understanding of quality management systems (ISO 9001, IATF 16949); audit experience is a plus.
• Proficient in MS Excel, Word, and PowerPoint.

______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact win@hkmsvs.com for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

Company Overview

Hanwha Ocean Energy Plant Unit transforms from a shipbuilder to an EPCI(O) solution provider, delivering FPSO, FLNG, Offshore Renewables, and Floating Production Units. It operates global business centers in North America and Asia to enhance project execution and client focus.

Job Summary

The Project Quality Manager leads the implementation of Quality Management Systems for offshore Oil and Gas EPCIO projects, ensuring compliance with industry standards and client requirements while driving quality excellence across project phases.

Responsibilities

• Develop and implement project-specific quality plans, procedures, and inspection/test plans (ITPs) to ensure quality standards are met
• Lead quality assurance, quality control, and testing activities during engineering, procurement, construction, installation, and operations & maintenance phases
• Ensure compliance with international standards such as ISO 9001, API, and ASME throughout project execution
• Conduct regular quality audits, inspections, and testing to monitor adherence to specifications and identify non-conformances
• Manage non-conformance issues and oversee timely resolution to maintain project quality integrity
• Review and approve quality documentation including plans and ITPs to align with project requirements
• Establish and track key performance indicators (KPIs) related to quality to monitor project performance
• Identify quality risks and develop mitigation plans to prevent potential issues
• Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) promptly
• Serve as the primary liaison for quality matters with clients, certification bodies, and regulatory authorities
• Provide senior management and stakeholders with regular reports on quality performance, risks, and mitigation strategies
• Drive continuous improvement by identifying opportunities for quality process enhancements and best practices
• Lead root cause analysis and corrective/preventive action processes to prevent recurrence of non-conformances
• Monitor and develop strategies to reduce the cost of non-quality across projects
• Stay informed on industry advancements in quality management tools and techniques to enhance project quality
• Facilitate the Lessons Learned review process and ensure collection of quality insights from projects
• Develop quality metrics and updates for Monthly Project Management Reviews

Required competencies and certifications

• Proven experience managing quality processes across large-scale offshore oil and gas EPCIO projects
• Strong knowledge of international quality standards including ISO 9001, API, and ASME
• Expertise in non-destructive testing (NDT) methods, welding standards, and material inspection
• Familiarity with offshore fabrication, installation, and inspection processes
• Strong leadership, communication, and decision-making skills to manage multiple stakeholders and project pressures
• Excellent analytical and problem-solving abilities focused on root cause analysis and process improvement

Preferred competencies and qualifications

• Bachelor’s degree in engineering, Quality Management, or related field
• Master’s degree is a plus

Lead the development and implementation of the organization's quality system strategy, ensuring compliance with food safety regulations, industry standards, and certifications. You will oversee operational processes, manage audits, and drive continuous improvement in quality assurance and control. Your role will also involve hands-on activities, including mock recalls, product labelling compliance, sampling, and supplier audits, to ensure product safety and quality.

Key Responsibilities:

• Develop and implement food safety management system in compliance with SFA licensing conditions, HACCP, ISO 22000, Halal, and other relevant standards
• Leading preparatory work for GACC registration/application to support exports to China
• Ensure compliance with local and international food safety regulations for both importation and exportation
• Oversee quality control (QC) processes, including sampling, testing, and record-keeping
• Review and ensure Standard Operating Procedures (SOPs) to align with industry regulations and company policies
• Lead internal and external audits, manage certification processes, and ensure compliance with food safety regulations
• Lead mock recall exercises to evaluate and improve the organization's recall readiness and traceability systems
• Ensure product labelling meets customer specifications and regulatory requirements, including allergen declarations, and country-specific labelling laws
• Develop and implement effective sampling for raw materials, in-process products, and finished goods
• Provide hands-on training and guidance to food safety team members on food safety management system and standards
• Investigate and resolve non-compliance issues, conduct root cause analysis and implement corrective and preventive actions (CAPA)
• Analyse data, test results, customer feedback, and audit reports to drive continuous improvement
• Liaise with local and other countries' authorities for importation and exportation issues

Job Requirements:

• Education: Degree in Food Science & Technology or a related discipline
• Experience: Minimum 5 years of experience in the food manufacturing industry with proven expertise in HACCP, ISO 22000, and quality management system
• Certifications: Internal Auditor/Lead Auditor certification preferred
• Skills and Competencies:

1. Strong leadership, project management, and problem-solving skills
2. Ability to implement Good Manufacturing Practices (GMP) and hazard analysis
3. Experience in auditing, documentation control, and technical report writing
4. Hands-on approach to quality control and sampling methodologies
5. Experience in conducting mock recalls and product traceability exercises
6. Knowledge of food labelling regulations and compliance requirements
7. Proficiency in sampling techniques, mock recall execution, and product labelling compliance
8. Ability to work collaboratively across departments and with suppliers
9. Excellent communication and interpersonal skills

Job Highlights

• Working Hours: Mon to Fri 7.30 am to 4.45 pm, alternate Sat 7.30 am to 11.45 pm (5.5 days)
• Great learning development opportunities.
• Work-life balance and positive/friendly working environment.

(Only shortlisted candidates will be notified)

Job Description & Requirements

Roles and Responsibilities:

• Lead a team of engineers comprising of process, mechanical and electrical engineers work on projects that involve multiple applications including SCADA, plant controls, telecommunications networks, and related systems.
• Prepare an overview after review of the Client’s IC&A strategy and compared it with project provisions.
• Preparation of Instrument List and cabling requirements and scope matrix will be your responsibility when procurement is required for the IC&A scope.
• Selection of instruments, analyzers and other control equipment to meet specification and design requirements for procurement.
• Review of technical submissions for compliance to project requirements and prepare technical submissions to client’s consultant and obtain approval in a timely manner.
• Prepare P&ID, process control narratives, instrument lists and I/O (input/output) or update client’s P&ID, process control narratives, instrument lists and I/O (input/output) as information from process equipment vendors become available. Issue project requirements to equipment vendors in accordance to the scope matrix of the IC&A package.
• Represent the Company at client and consultants meetings on IC&A matters.
• Review and understand the IC&A interfaces with other sub contracts or third parties and prepare a program to meet the interface milestones or bring to the attention of the supervising consultants in a timely manner on our requirements to meet construction program.
• Prepare Inspection and Testing Procedure for the IC&A Systems and lead in the testing and commissioning of the IC&A systems. Work with other disciplines from the Company and are expected to assist to ensure a full integration of process equipment controls.
• Manage the budget of the for the IC&A scope and prepare monthly report on the cash flow to the Project Manager.

Requirements:

• Possess at least Bachelor's Degree in Electrical & Electronic Engineering / Instrumentation & Control Engineering / Advanced Diploma in Process Control and Instrumentation.
• 10 years of EICA work experience, preferably in water/waste water projects.
• Experience in Selection, installation and Commissioning of Instruments.
• Experience in Basic Programming of PLC/DCS and SCADA.
• Experience in Project Execution, Supervising and Coordination with sub-contractors,consultant and Client.

Job Responsibilities

• Responsible for preparing technical and commercial, proposal according to customers' requirements.
• Provide a cost analysis for various solutions.
• Using technical skills to demonstrate to potential customers the benefits of the system and how it may sut the customer better thancompeting solutions.
• Sourcing and negotiate of components, parts for alternatives, cost effective when required.
• Participate in training, site inspection as assigned.
• Other ad-hoc duties as assigned.

Job Qualifications

• Diploma or Degree in Electrical/ Mechanical Engineering or with at least 1 year relevant working experienced.
• Basic knowledge of PLC, SCADA, and OPC.
• Able to read and interpret E&I drawingsand technical specifications.
• Strong analytical and problem solving skills.
• Good team player who can work independently and also cross-departmental.
• Able to work under pressure.
• Familiar with MS Office and AutoCAD.

• Quality Engineers oversee all quality-related activities of processes within their area of responsibility. They drive the continuous improvement of processes, products and services. Their deep know-how of processes and procedures will enable them to co-define and put through efficient and effective corrective measures. They strongly support production in decision-making and problem-solving routines, applying the latest tools.

Key Responsibilities

• Maintain and improve the Quality Management System in accordance with IATF 16949 requirements.
• Conduct internal process, system, and product audits, including follow-up and verification of corrective actions.
• Perform quality planning activities: APQP, PFMEA, Control Plans, PPAP, MSA, and SPC.
• Lead root cause analysis and corrective actions using structured problem‑solving tools (8D, 5 Why, Ishikawa).
• Review engineering drawings and specifications; ensure alignment with manufacturing and inspection requirements.
• Manage non-conformities, customer complaints, and CAPA activities.
• Support supplier quality tasks such as supplier audits, incoming inspections, and material disposition.
• Prepare and maintain quality documentation, reports, KPIs, and audit records.
• Drive continuous improvement initiatives to enhance product quality, process capability, and operational efficiency.

Metrology & Measurement Responsibilities

• Perform dimensional measurement and verification using a range of metrology and precision measurement tools.
• Operate and interpret results from measurement equipment such as:
• CMM (Coordinate Measuring Machine)
• Height gauges, micrometre, calipers
• Vision inspection systems
• Profile projectors, Smart scope
• Surface roughness testers
• Hardness testers
• Develop and maintain measurement procedures, inspection standards, and calibration documentation.
• Support calibration activities and ensure measurement equipment is maintained in accordance with metrology standards.
• Analýze measurement data and contribute to MSA studies (Gage R&R, bias, linearity).

Provide metrology training and technical support to production and quality

Lead the development and implementation of the organization's quality system strategy, ensuring compliance with food safety regulations, industry standards, and certifications. You will oversee operational processes, manage audits, and drive continuous improvement in quality assurance and control. Your role will also involve hands-on activities, including mock recalls, product labelling compliance, sampling, and supplier audits, to ensure product safety and quality.

Key Responsibilities:

• Develop and implement food safety management system in compliance with SFA licensing conditions, HACCP, ISO 22000, Halal, and other relevant standards
• Ensure compliance with local and international food safety regulations for both importation and exportation
• Oversee quality control (QC) processes, including sampling, testing, and record-keeping
• Review and ensure Standard Operating Procedures (SOPs) to align with industry regulations and company policies
• Lead internal and external audits, manage certification processes, and ensure compliance with food safety regulations
• Lead mock recall exercises to evaluate and improve the organization's recall readiness and traceability systems
• Ensure product labelling meets customer specifications and regulatory requirements, including allergen declarations, and country-specific labelling laws
• Develop and implement effective sampling for raw materials, in-process products, and finished goods
• Provide hands-on training and guidance to food safety team members on food safety management system and standards
• Investigate and resolve non-compliance issues, conduct root cause analysis and implement corrective and preventive actions (CAPA)
• Analyse data, test results, customer feedback, and audit reports to drive continuous improvement
• Liaise with local and other countries' authorities for importation and exportation issues

Job Requirements:

• Education: Degree in Food Science & Technology or a related discipline
• Experience: Minimum 5 years of experience in the food manufacturing industry with proven expertise in HACCP, ISO 22000, and quality management system
• Certifications: Internal Auditor certification preferred
• Skills and Competencies:

1. Strong leadership, project management, and problem-solving skills
2. Ability to implement Good Manufacturing Practices (GMP) and hazard analysis
3. Experience in auditing, documentation control, and technical report writing
4. Hands-on approach to quality control and sampling methodologies
5. Experience in conducting mock recalls and product traceability exercises
6. Knowledge of food labelling regulations and compliance requirements
7. Proficiency in sampling techniques, mock recall execution, and product labelling compliance
8. Ability to work collaboratively across departments and with suppliers
9. Excellent communication and interpersonal skills

Job Highlights

• Working Hours: Mon to Fri 7.30 am to 4.45 pm, alternate Sat 7.30 am to 11.45 pm (5.5 days)
• Great learning development opportunities.
• Work-life balance and positive/friendly working environment.

(Only shortlisted candidates will be notified)

REQUIREMENTS

• Diploma in Food Science, Food Technology or related disciplines
• Knowledgeable in local & international food safety standards
• Excellent communication and training skills

ROLES & RESPONSIBILITIES

1. Inspecting Raw Materials and Finished Products

• Assess the quality of raw materials, semi-finished, and finished food products.
• Ensure compliance with food safety standards, specifications, and government regulations.
• Conduct visual and physical inspections of products for defects, contamination, or spoilage.

2. Testing and Sampling

• Collect samples for laboratory analysis and ensure proper storage and labeling.
• Monitor critical control points (CCPs) to ensure compliance with safety protocols.

3. Compliance with Safety Regulations

• Ensure all products adhere to local and international food safety standards (e.g., SFA, Halal, HACCP, ISO 22000)
• Keep updated with regulatory changes and ensure production processes comply.
• Ensure proper documentation and record-keeping for audits and inspections.

4. Process and Equipment Monitoring

• Ensure production equipment is functioning properly and safely.
• Monitor environmental conditions such as temperature and humidity that may affect food quality.
• Implement calibration and validation of testing instruments.

5. Developing and Maintaining Quality Standards

• Design and update quality control protocols and standard operating procedures (SOPs).
• Train staff on quality standards and food safety regulations.
• Suggest improvements for production processes to enhance product quality and efficiency.

6. Reporting and Documentation

• Maintain detailed records of quality control tests, inspections, and non-conformances.
• Prepare reports summarizing findings and actions taken to correct issues.
• Investigate consumer complaints related to food quality and implement corrective actions.

7. Collaboration with Other Departments

• Work closely with production, procurement, and supply chain teams to resolve quality issues.
• Coordinate with regulatory agencies during audits or product recalls.
• Collaborate with R&D teams to ensure new products meet quality standards.

8. Conducting Audits and Investigations

• Conduct internal audits to ensure continuous compliance with quality standards.
• Investigate food safety incidents or production failures and take corrective/preventive actions.

9. Employee Training and Development

• Train employees on proper food safety practices, sanitation procedures, and quality control standards.
• Ensure workers are aware of personal hygiene standards and the use of protective gear.

10. Perform any other ad hoc duties as and when assigned by the department head

- assist quality assurance team in sample testing and administrative work
- handle purchase orders and liaise with suppliers
- track deliveries and ensure timely fulfillment
- maintain proper documentation for purchasing and QA
- supports audits or compliance checks / internal audit

Good to have: Food Safety / HACCP / GMP

Good to know: ISO 22000

Responsibilities : 

• Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements. 
• Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements. 
• Use Imex "ways of working" for day-to-day operations, problem solving, escalation and continuous improvements. 
• Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed. 
• Assess impact to products based on compendial monograph changes/updates/introduction. 
• Support regulatory submissions and queries for post transfer activity. 
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory. 
• Conduct Laboratory investigations and propose CAPA for the identified root cause. 
• Train colleagues in hands on training of instruments and methods written 
• Perform review and approval of test results. 
• Able to write position paper, protocols, reports and test procedures. 
• Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods. 
• Conduct trainings for fellow QC colleagues on new methods in the laboratory. 
• Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated. 
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
• Perform cleaning method development and validation. 
• Ensure following the site GDP practice on documentation and preparation of document. 
• Method verification in accordance to site or pharmacopeia standards and according to schedule. 
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.

Job Skill Requirements:

• Min. Degree with 5 years of QC Experience in pharmaceutical or related industries
• Demonstrated technical skills in method transfer, validation, verification and testing.
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures and governmental regulations
• Experienced in Method Transfer, Method Validation and Method Verification activity.
• Knowledge of cGMPs and ALCOA principles.
• Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment.
• Experienced in leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics

RESPONSIBILITIES:

To oversee QA department, ISO Quality System and maintains a smooth running and efficient department.

QA EXECUTIVE

• Oversee / liaising daily operations in QA Dept.
• Create quality control/assurance program that ensures all jobs comply with quality system standards.
• Field visit of jobsites for inspections, feedback analysis and follow-up on of customers’ complaints.
• Create & recommend innovation schemes to enhance quality culture.
• Document internal audits and other quality assurance activities.
• Collect and compile statistical quality data.
• Planning & prioritization of all test-related tasks.
• Preparing and completing action plan, implementing productivity, quality and customer-service standards, identifying and resolving quality assurance issues.
• Prepare reports to communicate outcomes of quality activities.
• Identify training needs and organize training interventions to meet quality standards.

QUALITY MANAGEMENT REPRESENTATIVE (QMR)

• Maintaining ISO 9001 Quality Management System.
• Conduct Internal Quality audits.
• Ensure all Quality Manual are updated.
• Prepare quarterly Management Report.
• Evaluation of service failures & customers complaints & recommendation.
• Coordinate and communication with external bodies on matters relating to quality management system.
• Coordinate and support on-site audits conducted by external providers.
• Responsible for document quality management systems.

REQUIREMENTS:

• Candidate must possess at least Diploma in any field.
• At least 2-3 Year(s) in quality assurance experience.
• Knowledge and maintain ISO 9001 QMS in manufacturing environment.
• Able to conduct internal audit.
• Proficient in Microsoft Office.
• Meticulous, self-started and motivated
• Able to work independently with initiative
• Good report writing and communication skills.

DUTIES & RESPONSIBILITIES

·        Perform 100% gate cutting and inspection of electroplated products in accordance with the work instructions and approved samples

·        Performpacking by following packing standard

·        Conduct5S at work areas

·        Preparelabel

CORE SKILL

·        Minimumtwo months’ relevant experience in gate cut and inspection work

·        Goodskill on gate cut and inspection

·        Knowledge on customer requirement