Senior QA Operations Executive (Materials)

gsk; Singapore; Vor Ort; SGD 80.000 - 100.000; Vollzeit

Zusammenfassung

GlaxoSmithKline is seeking a QA professional to lead quality assurance activities at our Singapore site. You will help maintain and improve the Quality Management System, support manufacturing, documentation and batch release, and collaborate with global teams to ensure regulatory compliance.

The role focuses on cGMP/GDP compliance, QA oversight of deviations and CAPAs, and material qualification. You will mentor junior QA staff and partner with cross-functional teams to drive continuous

Qualifikationen

• University degree in Science, Engineering or a related discipline.
• Minimum 5 years’ experience in Quality Assurance within the life sciences or pharmaceutical industry.
• Practical knowledge of current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP).
• Hands-on experience with deviations, CAPA, change control and batch review processes.
• Strong written and verbal communication skills and experience working with cross-functional teams.
• Proficiency with quality systems and electronic document or training platforms. Experience with SAP is a plus.
• Bachelor’s degree in a relevant science or engineering field if your basic degree is different.
• Experience with making quality decisions in a manufacturing setting.
• Prior exposure to regulatory inspections and presenting to regulatory or corporate auditors.
• Experience owning a site quality system or being a subject matter expert for a quality domain.
• Familiarity with quality metrics, trending and site-level quality council activities.
• Project or change management experience supporting system implementations or process improvements.

Aufgaben

• Lead QA activities to progress your career while ensuring cGMP compliance.
• Provide QA oversight for GMP record review, housekeeping checks, process confirmation, and SOP verifications.
• Offer QA input for deviation, CAPA, change controls and investigations.
• Manage material/supplier qualification in line with cGMP and internal procedures.
• Review and release incoming materials and sterile buffers in compliance with procedures.
• Review and approve LSOPs, checklists, deviations, CAPAs, and quality tags.
• Support site complaint investigations, periodic quality review, self-inspections and regulatory inspections.
• Mentor and coach junior QA staff to strengthen quality decision-making and execution.

Kenntnisse

Quality Assurance

cGMP

GDP

Deviations

CAPA

Change Control

Batch Review

Cross-functional Collaboration

Documentation

Risk Management

Technical Writing

Ausbildung

University degree in Science/Engineering or related discipline

Bachelor’s degree in science or engineering (preferred)

Tools

SAP

Jobbeschreibung

You will support and lead quality assurance activities at our Singapore site. You will help maintain and improve our Quality Management System and support manufacturing, training, documentation, and batch release activities. You will work with cross-functional teams and global colleagues to ensure compliance with regulations and company standards. We value people who are curious, practical, and committed to continuous improvement. Join us to grow your skills, make a meaningful impact, and contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Ensure cGMP compliance in incoming material management, warehouse, manufacturing support and related QC testing operations.
• Manage QA oversight activities including GMP record review, housekeeping checks, process confirmation, and SOP compliance verifications.
• Provide QA input for deviation / lab investigations, CAPA implementation, and change controls.
• Manage material / supplier qualification in compliance with cGMP requirement and internal procedures.
• Manage QA review and release of incoming materials and sterile buffers in compliance with cGMP requirement and internal procedures.
• QA review and approve LSOPs, checklists, incoming material documentations, deviations, CAPAs, change controls, and quality tag outs, in accordance with quality and compliance expectations.
• Support site complaint investigations, periodic quality review, self-inspections, risk assessments and/ or gap analyses, corporate or regulatory inspections.
• Mentor and coach junior QA staff to develop strong quality decision‑making skills and ensure effective execution of quality‑related tasks.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• University degree in Science, Engineering or a related discipline.
• Minimum 5 years’ experience in Quality Assurance within the life sciences or pharmaceutical industry.
• Practical knowledge of current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP).
• Hands-on experience with deviations, CAPA, change control and batch review processes.
• Strong written and verbal communication skills and experience working with cross-functional teams.
• Proficiency with quality systems and electronic document or training platforms. Experience with SAP is a plus.

Preferred Qualification

If you have the following characteristics, it would be a plus

• Bachelor’s degree in a relevant science or engineering field if your basic degree is different.
• Experience with making quality decisions in a manufacturing setting.
• Prior exposure to regulatory inspections and presenting to regulatory or corporate auditors.
• Experience owning a site quality system or being a subject matter expert for a quality domain.
• Familiarity with quality metrics, trending and site-level quality council activities.
• Project or change management experience supporting system implementations or process improvements.

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [e-mail]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.