Overview: Looking for Quality Assurance Manager at Leadership level at Ranjangaon, MIDC, Pune. Industry: Pharmaceuticals & Nutraceuticals (tablets/capsules/herbal products) Role & responsibilities To prepare the Batch Manufacturing and batch packing record To prepare process validation protocol, process validation report and stability protocol. To prepare the max hold study protocol and Hold study program. To maintain the change history of record. To issue Batch manufacturing record & Batch packing record. To Reconciliation of batch and review the BMR & BPR. To Issue SOPS, format, and register to the concern department. To co-ordinate with R& D, production, store, and engineering. Packaging material artwork checking Coordination with LL parties related to product manufactured. To verify reference sample and COA of finish products of LL Parties and gives clearance. To maintain record of reference sample, COA, and correspondence details of LL parties. To monitor shop floor activities. To perform additional task reported by the seniors / management. To check all analytical protocols are prepared to meet the pharmacopoeia. To ensure Calibration of equipment and instruments is performed as per specified schedules. To check for ATR (All time readiness) & Implementation of GLP system as per laid standards Raw data analysis, check protocols, STPs, COAs as per GMP practices. Review & receive method validation data, stability protocols, and sampling protocols. Review of Trend analysis, Annual Product Report Ensure the Installation, Operational and Performance Qualifications of Equipment related to laboratory (HPLC, GC, FT-IR etc.). maintain discipline in the department and GMP in all areas of the plant. To monitor, check and approve documentation like Change control deviation market complaint product recall etc. To review and monitor validation activities and self-inspection activities. conduct vendor audit. To Check/review/Approve documents like Quality Management System, Site Master File, Validation Master Plan and Qualification documents. To ensure overall cGMP implementation in the plant for better Quality, Safety and Efficacy of the products Preferred candidate profile QA Manager with minimum 10 years of working experience (minimum 4 years at leadership) level with Pharmaceuticals/Nutraceuticals Industry (tablet/capsules/herbal products) Able to lead & train a team of executives MS Chemistry working with reputed pharma brand /company Able to join within 30 days Directly reporting to Head of the plant Able to deal with different stakeholders across company and vendors Perks and benefits Medical Insurance Annual leaves Annual appraisals other compliance benefits If the above profile interests you then please share your updated CV on [HIDDEN TEXT] along with the following details: Total relevant experience in QA in Pharma Industry: Total experience at a AM/Managerial level: Total team size (directly reporting to you): Current fixed CTC: Expected fixed CTC: Notice period (in days): Are you ready with the Ranjangaon, Pune location: Yes/No