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
Immediate Joiner
Pharmaceutical experience only

📌 Production Executive Qms Bharuch
🏢 Milan Laboratories
📍 Bharuch