Supervise day-to-day QC activities for raw materials, packaging materials, in-process, finished products, and stability samples.
Review and approve analytical test results, worksheets, COAs, and laboratory records.
Ensure testing is performed according to approved specifications, SOPs, pharmacopoeial standards, and GMP requirements.
Handle and investigate OOS, OOT, deviations, laboratory incidents, and CAPA.
Ensure proper operation, calibration, qualification, and maintenance of laboratory instruments such as HPLC, GC, UV, dissolution, FTIR, pH meters, etc.
Review analytical methods, method validation/verification, and transfer activities.
Maintain laboratory compliance with GMP, GLP, data integrity, and regulatory requirements.
Coordinate with QA, Production, R&D, Engineering, and Regulatory Affairs for quality-related issues.
Train and supervise QC analysts and ensure adherence to laboratory safety and procedures.
Participate in internal audits, customer audits, regulatory inspections, and compliance activities.
Monitor laboratory performance, testing timelines, workload, and resource requirements.
Support preparation and review of SOPs, specifications, protocols, reports, and other QC documents.
Identify opportunities for improving laboratory efficiency, accuracy, and compliance.
Typical qualifications
B.Pharm, M.Pharm, B.Sc./M.Sc. Chemistry, or a related pharmaceutical/analytical science qualification.
4 - 10 years of pharmaceutical QC experience, preferably with supervisory or team-lead responsibilities.
Strong knowledge of GMP, GLP, pharmacopoeias, analytical techniques, OOS/OOT investigations, and data integrity.
Experience with regulatory expectations such as USFDA, WHO-GMP, MHRA, or local regulatory requirements is advantageous.