Assistant Manager- Analytical QA ( Qc reviewer + QMS) OSD

Job Description

Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and product quality. Collaborate with cross-functional teams (QC, Production, Regulatory Affairs, etc.) for continuous improvement. Desired Candidate Profile: Education: B.Pharm / M.Pharm / M.Sc in Chemistry or related field Experience: 10+ years of experience in Analytical Quality Assurance or QC in a pharmaceutical manufacturing environment, preferably in oral solid dosage (tablets) Hands-on experience in handling analytical investigations in a QC lab Experience in facing USFDA or other international regulatory audits Strong understanding of cGMP, ICH guidelines, and data integrity requirements Good communication and documentation skills