External Quality Assurance Specialist for Global Biopharma
5 days ago
9605 GSK Services Sp z o.o. is a leading global biopharma company dedicated to getting ahead of disease together.
Role OverviewWe are seeking an External Quality Assurance Specialist to support our quality relationship with assigned Contract Manufacturing Organizations (CMOs) / Suppliers in our external supply specific region.
Key Responsibilities- Recommend and implement continuous improvement of quality processes and procedures to ensure Good Manufacturing Practice (GMP) expectations for GSK's external CMOs/suppliers.
- Collect, monitor, and analyze quality performance indicators of the external CMOs/Suppliers using quality standards and tools to identify emerging trends and escalate significant risks requiring resolution.
- Provide regular reporting to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC).
- Liaise with key contacts at the External Supplier to ensure robust outcomes from quality & manufacturing systems, such as batch records, deviations investigations, change controls, validation activities, annual product reviews (APRs), and product disposition.
- Manage CMO/supplier change controls, deviations, and customer complaints within GSK systems.
- At least 1 year of experience in Technical, Regulatory or Quality Assurance roles with an understanding of quality systems and quality control processes.
- Demonstrated ability to make grade-level decisions based on facts and data and application of risk management principles.
- Fluent English communication skills.
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on location and experience. Our comprehensive benefits package includes life insurance, pension plan, private medical package, sports cards, and opportunities for professional growth and development within the company.
#LI-GSK
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