Senior QA Operations Lead, Materials (Pharma)

gsk

Singapore

On-site

SGD 80,000 - 100,000

Full time

12 days ago
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Job summary

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

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.
  • 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.

Responsibilities

  • 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.

Skills

Quality Assurance
cGMP
GDP
Deviations
CAPA
Change Control
Batch Review
Cross-functional Collaboration
Documentation
Risk Management
Technical Writing

Education

University degree in Science/Engineering or related discipline
Bachelor’s degree in science or engineering (preferred)

Tools

SAP

Job description

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

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