Assistant Manager – Quality (Lab Operations)
GSK · Karachi
Job description
About the role
The Assistant Manager Quality will support the Lab Operations Manager in ensuring that all laboratory equipment and processes meet GSK's cGMP, regulatory and QMS standards. This position focuses on equipment calibration, maintenance, audit support and quality reporting within the Penicillin laboratory.
Key responsibilities
- Maintain compliance with cGMP, regulatory and QMS requirements for laboratory operations.
- Oversee equipment calibration, maintenance and validation, including HPLC and related instrumentation.
- Manage purchase orders (OPEX) in Ariba, GRN punching and CAPEX asset procurement.
- Lead and participate in Level‑1 audits, self‑inspections and follow‑up actions for Level‑2/3 audits.
- Report out‑of‑specification (OOS) results, assist investigations and support CAPA implementation.
- Administer laboratory equipment inventory and act as Lead User for Empower software.
- Ensure adherence to EHS standards, report adverse events and attend relevant workshops.
- Facilitate equipment, chemicals and reagent purchasing and support validation activities.
Required profile
- Master’s degree in Chemistry, Pharmacy or a related scientific discipline.
- Minimum 5 years of laboratory experience in a regulated pharmaceutical or biotech environment.
- Strong knowledge of GMP, QMS and regulatory requirements.
- Proven experience with equipment qualification (IQ/OQ/PQ), method and cleaning validation.
- Excellent written and verbal communication with accurate documentation skills.
Required skills
- MS Office
- SAP
- LIMS
- ARIBA
- FIORI
- EMPOWER
- VEEVA
- KNEAT
- HPLC instrumentation
What we offer
- Opportunity to work within a global biopharma leader.
- Collaborative environment focused on continuous improvement.
- Access to cutting‑edge laboratory technologies and professional development.
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Published 1 month ago
Expires 3 weeks from now
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Karachi
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