Assistant QC Manager - Pharmaceuticals

Job title : Assistant QC Manager – Pharmaceuticals

Key Responsibilities

• 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.