Production Executive (QMS)

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