Audit Assistant Graduate Experience Jobs in Thane

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 standardsRequired Qualifications & Experience Education: B.Pharm / M.Pharm or M.Sc. 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.