798 Pharmaceutical Qa jobs in Singapore

Overview
The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation. We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.
Responsibilities
Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
Document validation activities and results and maintain records for all validation activities.
Analyse validation test data to determine whether systems or processes have met validation criteria.
Author validation reports.
Develop and maintain validation master plan.
Develop re-qualification or re-validation plans to keep the systems in validated states.
Support audits and inspections as a subject matter expert.
Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
Work closely with stakeholders to coordinate validation activities.
Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
Train staff on validation procedures and maintain documentation for audits.
Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications
Bachelor’s degree in Engineering, Pharmacy, Science or a related field.
Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
Proficient with validation software tools.
Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
Strong sense of accountability and ownership of responsibilities.
Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
A commitment to maintaining high standards of quality, safety, and compliance at all times.
Required Skills
Proficient with validation software tools.
Strong analytical, problem-solving, and organizational skills.
Excellent verbal and written communication skills.
Preferred Skills
Experience with audit management and regulatory inspections.
Prior work experience in the pharmaceutical or medical device industry.
Pay range and compensation package
Competitive salary and benefits package.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Pharmaceutical Manufacturing
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The Head of Quality oversees and directs all QA and QC activities to ensure that pharmaceutical products are developed, manufactured, and released according to stringent regulatory standards. The position is accountable for strategic leadership, regulatory compliance, GMP adherence, and continuous improvement, ensuring patient safety and product efficacy throughout the lifecycle. This is a greenfield pharmaceutical startup.
Responsibilities
Strategic and Regulatory Leadership
Establish, implement, and maintain robust quality management systems (QMS) aligned with cGMP, GLP, ICH guidelines, and other applicable standards (FDA, EMA, PIC/S, & HSA).
Set and communicate a clear quality strategy; ensure widespread understanding across the organization.
Serve as lead company representative during regulatory and certification audits/inspections, including FDA, EMA, MHRA, and local authorities.
Oversee quality system documentation, including SOPs, protocols, batch records, validation, and change control.
Quality Assurance (QA)
Lead all QA programs, including batch record review, final product release, CAPA, deviations, and risk management.
Continuously monitor compliance with GMP and quality regulations across facilities, personnel, and processes.
Conduct internal and supplier audits; ensure readiness for any external inspection.
Guide root cause analyses, continuous improvement efforts, and remediation plans in the event of non-conformities.
Quality Control (QC)
Oversee all QC operations, ensuring testing of raw materials, in-process samples, finished products, process validation, and environmental monitoring is timely and accurate.
Approve QC policies, test methods, and specifications ensuring validity and compliance.
Ensure appropriate investigation and resolution of OOS (out of specification) and OOT (out of trend) results.
Ensure all testing and reporting meet regulatory and company requirements for data integrity.
Lead, mentor, and motivate QA and QC teams; set clear objectives, conduct appraisals, and deliver ongoing training.
Develop a culture of accountability, quality, and operational excellence.
Oversee training programs to ensure compliance with current GMP, SOPs, and regulatory expectations.
Continuous Improvement and Reporting
Set, monitor, and report on key quality KPIs—CAPA effectiveness, audit outcomes, compliance rates, batch release turnaround, documentation compliance, and training completion.
Drive process improvements through risk assessments and proactive change management.
Qualifications
Bachelor’s or Master’s in Pharmacy, Chemistry, Life Sciences, or related field.
Minimum 10 years in pharmaceutical QA/QC, including 5+ in senior leadership.
Extensive knowledge of cGMP, GLP, GCP, ICH Q7/Q8/Q9/Q10, and international regulatory requirements.
History of successful regulatory inspections (e.g., FDA, EMA, HSA), audit leadership, and operational excellence.
Required Skills
Expert understanding of pharmaceutical regulations, QMS, and data integrity.
Strong leadership, organizational, team development, and communication skills.
Analytical, decisive, and solution-oriented with attention to detail.
Skilled in process improvement, problem-solving, risk management, and change control.
Get notified about new Head of Quality Assurance jobs in
Tuas, West Region, Singapore .
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Location: Tuas (Walking distance from MRT)
Working hours: Monday to Friday (8.00 am to 5.15 pm)
Salary: $4,000 - $5,000
Main Duties
Responsible for collaborating with all Business Units' (BUs) to collate and analyze monthly data for performance trend analysis and prioritize quarterly governance action plans
Working together with BUs’ on external audits, Request For Change (RFC), quality risk assessment, to identify continuous improvement areas, with aim to promote food safety culture within the organization
Act as leader for GTQM Resource Database
Maintain and update resource documents for Group TQM and BUs as per company's requirements.
Support to create Group R&D policies, guidelines, and procedures aligned with international standards.
New / alternative vendor qualification for ingredient (RM), Packaging (PM)
Activities include document review, supplier liaison, technical assessment, and audits to meet standards before listing on the Approved Vendor List.
New lines / change of equipment Process Qualification PQ, which involves sterility test plan designing and execution; cleaning and sanitation (CIP) and Hygiene verification to meet requirements
To develop and maintain Quality Plan program for all Business Units, coordinate and engage BUs’ key stakeholders for Quality Plans alignment for implementation
Any other assignments /projects that assigned by superior, to meet business needs
Requirement
Min. Degree holder in Food Technology, Food Science or related Science / Engineering fields
Has minimum 5 years QA/QC working experience in dairies / beverage industry
Willing to travel for business purposes
Possess knowledge and experience in food packaging qualification, certified lead auditor are added advantages
If interested, please send me your most updated resume to WA: or email me at:
All candidates’ information will be treated with the strictest confidence
Katherine Carlen
CEI.No: R
Recruit Express Pte Ltd
EA Licence No: 99C4599
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Location: Tuas (Walking distance from MRT)

Working hours: Monday to Friday (8.00 am to 5.15 pm)

Salary: $4,000 - $5,000

Main Duties:

• Responsible for collaborating with all Business Units' (BUs) to collate and analyze monthly data for performance trend analysis and prioritize quarterly governance action plans
• Working together with BUs’ on external audits, Request For Change (RFC), quality risk assessment, to identify continuous improvement areas, with aim to promote food safety culture within the organization
• Act as leader for GTQM Resource Database
  • Maintain and update resource documents for Group TQM and BUs as per company's requirements.
  • Support to create Group R&D policies, guidelines, and procedures aligned with international standards.
• New / alternative vendor qualification for ingredient (RM), Packaging (PM)
  • Activities include document review, supplier liaison, technical assessment, and audits to meet standards before listing on the Approved Vendor List.
  • New lines / change of equipment Process Qualification PQ, which involves sterility test plan designing and execution; cleaning and sanitation (CIP) and Hygiene verification to meet requirements
  • To develop and maintain Quality Plan program for all Business Units, coordinate and engage BUs’ key stakeholders for Quality Plans alignment for implementation
  • Any other assignments /projects that assigned by superior, to meet business needs

Requirement

• Min. Degree holder in Food Technology, Food Science or related Science / Engineering fields
• Has minimum 5 years QA/QC working experience in dairies / beverage industry
• Willing to travel for business purposes
• Possess knowledge and experience in food packaging qualification, certified lead auditor are added advantages

If interested, please send me your most updated resume to WA: or email me at:

All candidates’ information will be treated with the strictest confidence

Katherine Carlen

CEI.No: R

Recruit Express Pte Ltd

EA Licence No: 99C4599

• Management corrective action request system to improve quality performance and ensure compliance with ISO9001, ISO14001 and IATF14969.
• Schedule, manage and assist the internal audit program and third-party certification audits.
• Maintain all documentation for the Quality Management System.
• Manage timely response to customer quality management system questionnaires.
• Facilitate formal Root Cause Analysis of quality and other incidents periodically.

Requirements:

• Minimum of 3 years of relevant experience in a manufacturing environment and quality assurance activities (Audits, CARs, RCA)
• Excellent working knowledge of relevant quality management standards (ISO9001, ISO14001, IATF16949) and related management systems
• Training and experience in utilization of Root Cause Analysis methods in a manufacturing environment
• Soft skills to act as a facilitator for audits, incident and quality issue investigations and enable teamwork with different departments and teams in the plant, across the business and with global quality teams
• Professional written, verbal and presentation skills including proficiency in data analysis and communication.
• Familiar with FMEA or other risk analysis methods preferred.
• Proficiency with Power BI document management and workflow preferred.

***

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Manfield Employment Services Pte Ltd

EA Licence No: 95C2823

Posting Personnel: Quennie Chen

EA Personnel Registration No: R

Job Description

1. Provide expert consulting on designing, optimizing, and implementing global and U.S., specific quality management systems, ensuring alignment with alignment with industry best practices and regulations.

2. Support GCP - compliant software development/maintenance quality assurance, with a focus on meeting U.S. standards (e.g., FDA, ICH GCP).

3. Advise on internal audit planning, execution, and follow-up to align with U.S. regulatory expectations and identify process improvements.

4. Support U.S. market system certifications (e.g., ISO 13485, FDA21 CFR Part 11), including audit preparation and compliance.

5. Collaborate with cross-functional teams (R&D, Engineering, Product) to provide quality guidance, resolve compliance issues, and boost quality awareness.

Monitor U.S. regulatory updates (e.g., FDA guidelines, GCP changes) and deliver timely insights to stakeholders for ongoing compliance.

Working Location: Jurong Island

Working Hours: Monday - Friday, 8AM - 4.30PM

Company transport: Near Jurong East MRT Station

Responsibilities:

• Manage and maintain the organization's EVAL Quality Management System (QMS) to ensure compliance with ISO9001:2015, ISO14001:2015, and IATF16949 standards.
• Report QMS status and performance updates to site leadership on a regular basis.
• Oversee the Corrective Action Request (CAR) system to drive quality improvements and ensure compliance with industry and customer standards.
• Plan, manage, and support internal audits as well as third-party certification audits.
• Maintain accurate and up-to-date documentation for the Quality Management System.
• Coordinate timely responses to customer quality questionnaires.
• Lead and facilitate Root Cause Analysis (RCA) for quality issues and incidents.
• Collaborate with cross-functional teams to drive corrective actions and continuous improvements.

Requirements:

• Bachelor's degree in Engineering or a related field.
• Minimum 3 years of relevant experience in quality assurance within a manufacturing environment (including audits, CARs, and RCA).
• Solid knowledge of ISO9001, ISO14001, and IATF16949 standards and QMS practices.
• Trained and experienced in Root Cause Analysis methods.
• Strong facilitation and interpersonal skills to lead audits, investigations, and cross-team collaboration.

• Excellent written, verbal, and presentation skills, with proficiency in data analysis and reporting.

• Familiarity with FMEA or other risk analysis methods will be an added advantage.

• Experience with Power BI, document management, and workflow systems will be an added advantage.

We regret that only shortlisted candidates will be notified.

Interested applicants kindly click on "apply now" or send your updated resume to

Jayden Kua Jing Yu

Registration Number: R

EA License Number: 02C4944

People Profilers Pte Ltd, 20 Cecil St, #08-09, PLUS Building, Singapore

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

*QA Specialist (Senior/ Associate Principal) *

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That's what makes us Roche.

As a QA Specialist in the Quality Systems and Compliance department, you are responsible for providing quality oversight and managing all related activities in line with Roche policies, standards, procedures, and Global cGMPs. Your functional duties include managing regulatory inspections and corporate GMP audits, managing the internal inspection readiness program, and overseeing the systematic evaluation of new and emerging regulations. You'll also be responsible for supplier management, trending quality compliance performance, and acting as a regulatory liaison by addressing queries from Health Authorities and internal partners. Additionally, you will play a key role in  leading the execution and ongoing monitoring of Quality System elements, including Quality Management Systems (QMS), Annual Product Quality Review (APQR), Management Review of Quality (MRoQ), Quality metrics and Quality Risk Management (QRM).

*The Opportunity *

• Audit and Inspection Management: Oversee regulatory inspections, internal and external audits, and manage the site's self-inspection program to drive continuous improvement.
• Inspection Readiness: Develop and lead all site inspection readiness activities, including managing responses and mitigation plans for any observations.
• Compliance Risk Management: Manage the compliance risk program, keeping the site informed about new requirements and emerging trends.
• Supplier Quality: Support GxP supplier  management and collaborate with the Global Supplier Quality team to maintain GxP agreements.
• Regulatory Liaison: Act as a key liaison with PT Regulatory, coordinating between the site and PTR, and managing import and distribution licenses with affiliates.
• Quality Systems Oversight: Manage the site's Quality Systems program to ensure it's effective, efficient, and compliant with all relevant regulations.
• Risk Management: Oversee the risk management program to ensure potential product and patient risks are systematically assessed and documented.
• Continuous Improvement: Ensure the continuous improvement of the Quality Management System (QMS) processes, including the Site Master File, MRoQ, Quality Risk Management, and APQR.

*Who you are *

• Education and Experience: A degree in Science or Engineering with a minimum of five years of relevant experience in a pharmaceutical setting.
• Industry Knowledge: Strong understanding of Quality System principles, cGMP, and both local and international regulations, with a familiarity with Operations.
• Audit and Compliance Expertise: Proven knowledge of audit or inspection management and a strong analytical ability to interpret and apply quality standards.
• Leadership and Teamwork: A detail-oriented leader with excellent communication skills who can work both independently and collaboratively under pressure.
• Professional Skills: Demonstrated ability to make sound decisions, manage priorities, and build strong relationships to drive results.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

About the Role

We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record review, and regulatory readiness.

Key Responsibilities

• Batch Record Review (BMRs): Review and approve batch records, ensuring that all documentation is complete and accurate. Handle deviations and discrepancies, ensuring they are properly documented, investigated, and resolved.
• Deviation Management: Manage and investigate deviations, ensuring corrective and preventive actions (CAPA) are implemented to resolve quality issues.
• Change Control: Support and manage change control processes to ensure all changes are evaluated, documented, and approved in compliance with GMP requirements.
• Quality Systems & Compliance: Oversee quality systems activities such as cleaning validation, documentation reviews, and ensuring ongoing audit readiness.
• Regulatory Inspections: Support preparations for regulatory inspections (FDA, EMA, NPRA, etc.), ensuring all documentation and processes are in compliance with regulatory requirements.
• Data Integrity: Apply data integrity principles (ALCOA/ALCOA+) to maintain the reliability, completeness, and accuracy of all data within QA processes.

Requirements

• 3+ years of experience in a QA role within the pharmaceutical biologics industry, with hands-on experience in batch record review, deviation management, and CAPA processes.
• Strong understanding of GMP guidelines, quality systems, and compliance activities.
• Familiarity with regulatory inspections and experience in preparing for or supporting audits (FDA, EMA, NPRA, etc.).
• Knowledge of data integrity principles (ALCOA/ALCOA+) and demonstrated ability to apply them in QA operations.
• Excellent attention to detail with strong problem-solving skills and the ability to handle complex compliance challenges.