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 robust 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

📌 Sr. Executive/Asst. Manager - QMS (Ahmedabad)
🏢 Quality HR Services
📍 Ahmedabad