An Assistant Manager - Quality Control (QC) [Formulation] in a pharmaceutical company manages day-to-day laboratory operations, analytical testing, and compliance for drug formulations (such as tablets, capsules, liquids, or injectables) to ensure adherence to Current Good Manufacturing Practices (cGMP) and pharmacopeial standards
Required Qualifications & Experience
• Education: m / m or . in Chemistry / Analytical Chemistry / Biochemistry
• Experience:
• Typically 5 to 10 years of hands-on experience in a pharmaceutical formulation manufacturing or R&D setup, with at least 2-3 years in a supervisory or assistant managerial role.
• Technical Skills:
o Hands-on proficiency in modern analytical instrumentation (HPLC, GC) and data integrity guidelines (ALCOA+).
• Strong knowledge of Pharmacopoeias, ICH guidelines, and stability testing
• Soft Skills:
o Leadership, problem-solving, cross-functional communication, and audit-facing capability.
Key Responsibilities
• Laboratory Operations & Testing:
o Supervise and review testing of Raw Materials (RM), Packing Materials (PM), Water Systems (WFI/Purified Water), In-Process samples, and Finished Goods (FG) for formulation products.
• Ensure timely analysis using advanced analytical instruments such as HPLC, GC, UV-Vis, Dissolution Testers, FTIR, and LIMS. Compliance & Documentation:
o Review and approve Certificates of Analysis (CoA), raw data, standard operating procedures (SOPs), and analytical method validation/verification (AMV) protocols.
• Ensure strict compliance with cGMP, GLP, and pharmacopeial standards (USP, BP, EP, IP). Investigations & CAPA:
o Handle Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory incidents.