Role & responsibilities

- Manage and coordinate QMS activities related to Production operations.
- Initiate, review, assess, and monitor Change Controls related to production processes, equipment, facilities, documents, and systems.
- Manage Deviation investigations, including identification of root cause, impact assessment, investigation, and timely closure.
- Initiate and monitor CAPA (Corrective and Preventive Action) based on deviations, incidents, audit observations, complaints, and other quality events.
- Ensure effective Root Cause Analysis (RCA) using appropriate investigation tools such as 5-Why, Fishbone, etc.
- Coordinate and review equipment, facility, process, cleaning, and utility qualification/validation activities as applicable.
- Ensure qualification documents, protocols, reports, and related QMS records are completed accurately and within timelines.
- Review and ensure compliance of SOPs, BMR/BPR, protocols, reports, and other production-related documents.
- Monitor the timely completion and effectiveness checks of CAPA and Change Controls.
- Participate in internal audits,



regulatory inspections, customer audits, and QMS reviews.
- Ensure timely implementation and closure of audit observations and compliance actions.
- Coordinate with QA, QC, Engineering, Validation, Warehouse, and other cross-functional departments for QMS activities.
- Identify potential quality risks and support implementation of appropriate risk assessment and mitigation measures.
- Ensure adherence to GMP, data integrity, SOPs, and applicable regulatory requirements.
- Prepare and review QMS-related reports, trackers, and management review data.
- Provide training and guidance to Production personnel on QMS procedures, deviations, CAPA, change control, and compliance requirements.
- Ensure proper documentation, traceability, and timely closure of all assigned QMS activities.
- Drive continuous improvement initiatives within Production and QMS processes.

Preferred candidate profile

1. Immediate Joiner

2. Pharmaceutical experience only

📌 Production Executive (QMS) (Bharuch)
🏢 Milan Laboratories
📍 Bharuch