Assistant Manager Production Quality Management System

Role & Responsibilities

• Drive effective implementation and continuous improvement of QMS requirements within the Production function.
• Manage and monitor deviations, incidents, OOS/OOT, CAPA, change controls, risk assessments and investigations related to manufacturing.
• Coordinate with QA, QC, Engineering, Warehouse and Production teams for timely investigation and closure of quality events.
• Review BMR/BPR, SOPs, logbooks, formats and GMP documentation for compliance.
• Support APQR/PQR, audits, self-inspections, customer audits and regulatory inspections, including closure of observations.
• Monitor CAPA effectiveness, audit commitments and change management impacting product quality and compliance.
• Participate in QRM/FMEA activities and identify opportunities to reduce recurring deviations and improve manufacturing processes.
• Monitor production quality trends including deviations, yields, rejections and reconciliation.
• Ensure compliance with cGMP, WHO-GMP, Schedule M, ALCOA+, data integrity and GDP requirements.
• Conduct GMP/QMS training for Production personnel and maintain QMS trackers, dashboards and management reports.

Preferred Candidate Profile

• B.Pharm / M.Pharm / B.Sc / M.Sc / B.Tech or equivalent qualification.
• 5-12 years of experience in Pharmaceutical Manufacturing / Production QMS.
• Candidates with experience in a pharmaceutical formulation manufacturing plant will be preferred.
• Strong hands-on experience in QMS, GMP, deviations, CAPA, change control, OOS/OOT and investigations.
• Good knowledge of RCA, 5 Why, Fishbone, FMEA, QRM and risk assessment.
• Exposure to audits, regulatory inspections, APQR/PQR, data integrity and ALCOA+.
• Strong documentation, analytical, problem-solving and cross-functional coordination skills.
• Candidates should be comfortable working closely with Production and QA and managing multiple QMS activities within defined timelines