Job Summary
The Assistant Manager Quality Control is responsible for ensuring accurate, compliant, and reliable analytical operations within the pharmaceutical QC laboratory. The role involves performing and overseeing analysis and calibration of sophisticated analytical instruments such as HPLC, GC, IC, and ICP-MS to support routine testing and regulatory requirements. The position requires effective management of working standard qualification and reference standard control to maintain data integrity. The incumbent will lead investigations related to OOS, OOT, and deviations, including root cause analysis and implementation of CAPA to prevent recurrence
Key Responsibilities
- Strong expertise in analysis, troubleshooting, and calibration of HPLC, GC, IC, and ICP-MS.
- Proven experience in working standard qualification, reference standard management, and data integrity practices.
- Skilled in OOS, OOT, and deviation investigations, including root cause analysis and CAPA implementation.
- Hands-on experience in review and approval of analytical data, reports, and QC documentation.
- Well-versed in cGMP, SOPs, and regulatory compliance requirements.
- Effective coordinator with cross-functional teams and experience supporting audits and inspections.
Education: B.Sc / M.Sc (Chemistry or relevant discipline)
Experience: 810 years in Pharmaceutical
Skills: analysis and calibration of hplc, gc, ic and icp& ms,calibration,investigation of oos, oot and deviation
