1. Role Purpose

The QMS Section in Charge shall be responsible for managing and maintaining the site Quality Management System to ensure compliance with GMP, GDP, ICH Q7, ISO requirements, customer expectations, and applicable regulatory standards. The role is accountable for effective control of QMS records, documentation systems, CAPA implementation, audit readiness, validation/qualification review, and continual improvement of quality systems.

2. Key Responsibilities
- Manage QMS activities including deviations, incidents, change controls, CAPA, OOS/OOT, complaints, recalls, returns, market complaints, and quality risk management.
- Ensure preparation, review, approval, issuance, revision, archival, retrieval, and destruction of GMP documents, SOPs, formats, quality manuals, and controlled copies.
- Review and monitor QMS records in TrackWise/eQMS/DMS and ensure timely closure of actions with appropriate investigation, root cause, impact assessment, CAPA, and effectiveness checks.
- Prepare and review QMS trend reports, quality system review reports, management review inputs,



and audit compliance reports.
- Review validation/qualification protocols and reports for equipment, utilities, facilities, instruments, manufacturing processes, cleaning processes, and computerized systems.
- Participate in internal, customer, vendor, and regulatory audits; coordinate audit responses and ensure timely closure of observations and CAPA.
- Conduct plant rounds to verify GMP, GDP, data integrity, hygiene, safety, and procedural compliance.
- Support finished goods release, dispatch documentation review, BPCR/ECR/PCCR review, IPQA/data review activities, calibration review, vendor qualification, reserve sample management, and EHS compliance.
- Coordinate with Production, QC, Engineering, Warehouse, EHS, Regulatory Affairs, and other departments for effective implementation of quality systems.
- Perform delegated responsibilities in the absence of senior QA personnel and ensure

📌 Associate Manager QMS (Barnala)
🏢 IOL Chemicals and Pharmaceuticals
📍 Barnala