Job Duties:

• Provide day-to-day quality oversight for QC laboratory and production-related activities in a GMP environment.

• Review, verify, and approve analytical testing data to support timely product and batch release.

• Review and approve QC documentation, including batch records, AS&T documents, and Master Batch Records (MBRs).

• Support batch disposition and release activities in alignment with Quality and regulatory requirements.

• Lead and execute end-to-end qualification of QC laboratory equipment (Group B & C), ensuring compliance with GMP standards.

• Develop, review, and approve qualification documentation, including URS, ERES, HLRA, IOQ, PQ, and Qualification Reports.

• Manage and execute change controls related to QC equipment qualification and lifecycle management.

• Support deviations, investigations, and exception handling, contributing to root cause analysis and corrective actions.

• Provide quality guidance for non-routine QC activities, new product introductions, tech transfers, and improvement projects.

• Support internal and external audits, maintain audit readiness, and actively contribute to continuous improvement and OpEx initiatives.
  

Job Requirements:

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Biochemistry, or a related scientific discipline.

• 3–5 years of hands-on experience in pharmaceutical Quality Control, Quality Assurance, or Manufacturing Quality.

• Proven experience in QC equipment qualification and validation within GMP-regulated environments.

• Strong working knowledge of cGxP requirements, data integrity principles, and regulatory compliance standards.

• Demonstrated ability to author, review, and execute qualification documentation (URS, IOQ, PQ, QR, etc.).

• Experience supporting deviations, investigations, audits, inspections, or regulatory interactions is preferred.

• Exposure to tech transfers, new product introductions, or QC process improvement initiatives is advantageous.

• Strong stakeholder management skills with the ability to collaborate effectively across cross-functional teams.

• Proficiency with electronic documentation systems, quality IT tools, and MS Office applications.

• Detail-oriented, results-driven professional with a strong continuous improvement and compliance mindset.
  

To Apply, please kindly email your updated resume to [email protected]

Regret to inform that only shortlisted candidates will be notified.

CEI: R25127749

EA License: 14C7275