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 prospects 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