Sr. Executive/Asst. Manager - QMS

Job Summary

Position: Sr. Executive/Asst. Manager - QMS

Location: Ahmedabad

Experience: 5 - 12 Years

Industries: Pharma

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 Skills

• QMS
• GMP
• CAPA
• FMEA
• Root Cause Analysis
• 5 Why
• Risk Assessment
• BMR/BPR
• SOPs

Required Qualification

B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Key Skills