Assistant Manager - API Quality Assurance

Job Description

Preferred candidate profile Masters (Pharmaceutical Chemistry / Organic Chemistry/ Quality Assurance) with 2-3 yrs. experience in Process /synthetic chemistry and 6-7 yrs. experience in QA role with API GMP QA experience Role & responsibilities Prepare and Review Standard Operating Procedures and Guidelines for DQA. Review documents with respect to drug substance such as protocols, SOPs, test methods, data, BMR, BPR, ROAs, COAs and reports through collaboration with PRD, ARD and QC scientists, to achieve the highest quality from technical and compliance perspectives. Review process development documents including KSM/KRM identification, specification proposal, analytical method development/validation reports, stability protocols & reports, and safety studies. Responsible for investigations against laboratory Incidents, OOS, OOT encountered with aim of root cause identification and CAPA implementation. Responsible for assessing the impact, review and closure of Change control requests and Deviations. Responsible for CAPA implementations, verification of and effectiveness. Responsible for maintaining the Quality Metrics and preparation of Quality Metrics. Plan, execute internal audits, external audits and communicate audit schedules, outcomes to audit stakeholders ensuring CAPA appropriateness for closure, audit trending for continual quality improvement. Review and approval of Stability management activities of Drug substance and Drug products such as Stability Protocol, data and stability summary report. * Note : We are not looking for IPQA, CQA/Analytical QA personnel. Candidates with experience in review of process development documents including KM, KRM identification , specification proposals and API QA experience are required.