Senior QA Operations Executive (Materials)

GlaxoSmithKline Pte Ltd

Singapore

On-site

SGD 90,000 - 130,000

Full time

2 days ago
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Job summary

GlaxoSmithKline Pte Ltd in Singapore seeks a Quality Assurance professional to lead QA activities and enhance the Quality Management System. You will support manufacturing, training, documentation, and batch release, collaborating with cross‑functional and global teams to ensure regulatory and internal standards are met.

The role emphasizes cGMP and GDP compliance, deviation management, CAPA, change control, and site quality leadership.

Qualifications

  • 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.

Responsibilities

  • Lead QA activities to ensure cGMP compliance across materials, warehouse, manufacturing support and QC testing operations.
  • Oversee GMP record review, housekeeping checks, process confirmations, and SOP verifications.
  • Provide QA input for deviations, CAPA, change controls and batch releases.
  • Manage material/supplier qualification in line with cGMP and internal procedures.
  • Review and approve LSOPs, checklists, deviations, CAPAs, change controls, and related quality documentation.
  • Support site investigations, periodic quality reviews, self-inspections and regulatory inspections.
  • Mentor and coach junior QA staff to strengthen quality decision-making and execution.

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

Education

Bachelor’s degree in Science/Engineering

Job description

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 QualificationWe 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 QualificationIf 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 @gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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