Posted:1 month ago|
Platform:
Work from Office
Full Time
Position Title : Executive / Sr. Executive / Assistant Manager QMS Department : Quality Assurance (QA) – QMS Section Location : Formulation- IV, Jarod Experience : 5 to 8 years (in regulated pharmaceutical manufacturing, specifically solid oral dosage forms) Key Responsibilities: Ensure implementation, maintenance, and continuous improvement of the site Quality Management System in compliance with cGMP, ICH guidelines, and regulatory requirements (USFDA, MHRA, EU, etc.). Review and control of GMP documentation including SOPs, Quality Manuals, Validation Master Plans, etc. Handling of deviations, change controls, CAPAs, and risk assessments. Oversight and coordination of internal audits, self-inspections, and participation in regulatory and customer audits. Management of Product Quality Reviews (PQR/APQR) and Quality Metrics. Support in QMS training programs for cross-functional teams. Assist in the evaluation and qualification of vendors through QMS processes. Manage document lifecycle in the electronic documentation management system (EDMS). Drive quality culture and continuous improvement initiatives across the site. Qualifications: B.Pharm / M.Pharm / M.Sc. in a relevant scientific discipline. Strong knowledge of QMS principles and pharmaceutical quality systems in oral solid dosage manufacturing. Experience with regulatory inspections (USFDA, MHRA, WHO, etc.) and audit readiness. Proficiency in handling QMS software systems (TrackWise, Veeva, MasterControl, etc. is a plus). Good understanding of data integrity principles and quality risk management. Key Skills: Excellent documentation and communication skills. Analytical and problem-solving mindset. Ability to work cross-functionally and lead quality initiatives. Attention to detail and a proactive approach.
Alembic Pharmaceuticals
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