Job Purpose
Responsible for implementation, monitoring, and continuous improvement of QMS activities within the Production function, ensuring compliance with cGMP, WHO-GMP, regulatory requirements, SOPs, and company quality standards.
Key Responsibilities
• Ensure effective implementation of QMS requirements within the Production department.
• Prepare, Review, initiate, investigate, and monitor deviations, incidents, OOS/OOT, change controls, CAPA, and risk assessments related to Production.
• Coordinate with QA, QC, Engineering, Warehouse, and other cross-functional teams for timely investigation and closure of quality events.
• Review and ensure compliance of BMR/BPR, SOPs, logbooks, formats, and other GMP documentation.
• Support preparation and review of Annual Product Quality Review (APQR/PQR) data related to Production.
• Monitor CAPA effectiveness and ensure timely closure of commitments.
• Conduct and support self-inspections, internal audits, customer audits, and regulatory inspections.
• Ensure timely implementation of audit observations and track action plans to closure.
• Participate in QRM/FMEA activities for manufacturing processes, equipment, and quality risks.
• Identify opportunities for process improvement, compliance enhancement, and reduction of recurring deviations.
• Review production trends, deviations, yields, rejections, reconciliation, and other quality-related performance indicators.
• Ensure adherence to data integrity, ALCOA+ principles, GDP, GMP, and documentation practices.
• Provide GMP/QMS training to Production personnel and monitor training effectiveness.
• Support implementation and periodic review of SOPs, Work Instructions, Master Documents, and other controlled documents.
• Ensure timely investigation and closure of market complaints, product quality issues, and regulatory commitments related to manufacturing.
• Maintain QMS trackers, dashboards, and periodic management reports.
• Ensure effective implementation of change management and assessment of changes impacting product quality and regulatory compliance.
• Coordinate with QA for batch review, investigation closure, and product disposition-related activities.
• Promote a strong quality culture and right-first-time approach within Production.
Required Qualification
• B.Pharm / M.Pharm / B.Sc / M.Sc / B.Tech or equivalent qualification.
• Experience in a pharmaceutical formulation manufacturing plant preferred.
• Strong knowledge of cGMP, WHO-GMP, Schedule M, data integrity, QMS, deviation, CAPA, change control, risk management, and audit compliance.
Key Skills
• Strong knowledge of Pharmaceutical QMS and GMP.
• Good investigation and root-cause analysis skills.
• Knowledge of 5 Why, Fishbone, FMEA, CAPA, and risk assessment.
• Good documentation and report-writing skills.
• Strong analytical and problem-solving capability.
• Effective coordination with cross-functional teams.
• Good communication and interpersonal skills.
• Ability to manage multiple QMS activities and meet timelines.
• Proficiency in MS Excel, Word, PowerPoint, and QMS/SAP systems.
