GM

Job Description : GM – QA | PHARMA CANADA ???? Industry: Pharmaceutical – OSD Manufacturing 20 Years ???? Salary: Up to CAD 250,000 OSD Manufacturing + USFDA Exposure + IPQA + Qualification/Validation + Strong QA Leadership Experience is mandatory ?? CANDIDATE PROFILE – STRICT REQUIREMENT ? Only candidates from USFDA-approved Pharma Manufacturing Plants ? Strong & hands-on experience in OSD Manufacturing QA ? Proper knowledge of IPQA & Qualification/Validation ? Minimum 3+ Years of Managerial / Leadership Role experience is mandatory ? CQA-only candidates will NOT be considered ???? KEY RESPONSIBILITIES • Provide strategic leadership for the complete QA function of OSD Manufacturing Plant. • Lead and oversee IPQA activities across manufacturing, dispensing, compression, coating, granulation, packing and other critical areas. • Drive Qualification & Validation activities including process validation, cleaning validation, equipment qualification and validation lifecycle management. • Ensure complete compliance with USFDA, cGMP, WHO-GMP and other applicable regulatory requirements. • Lead QMS, deviations, CAPA, change control, OOS/OOT, investigations and risk management. • Ensure effective implementation of Batch Record review, SOP compliance, line clearance and in-process controls. • Lead preparation and management of USFDA / Regulatory inspections and customer audits. • Review and approve critical validation protocols, reports, deviations, CAPA and change controls. • Establish strong quality culture across Production, QC, Engineering, Warehouse and other cross-functional teams. • Drive continuous improvement, data integrity and GMP compliance across the plant. • Mentor and develop the QA team while ensuring effective manpower planning and performance management. • Act as the key QA leadership interface with Plant Head, Corporate QA, Regulatory Affairs and Senior Management. • Ensure product quality, patient safety, regulatory compliance and timely release of products.

---