Key Responsibilities:

Lead and manage the overall Quality Assurance function for manufacturing operations.

Ensure compliance with GMP, GDP, SOPs, regulatory requirements and customer quality requirements.

Review and approve BMR, BPR, MFR and other manufacturing/testing documentation.

Oversee batch record review, verification, batch closure and final product release/rejection.

Ensure proper issuance, review, retrieval, control and archival of QA documents.

Manage deviations, incidents, OOS/OOT investigations, CAPA and Change Controls.

Review and approve root-cause investigations and corrective/preventive actions.

Oversee Process Validation, Cleaning Validation, Equipment Qualification and other validation activities.

Conduct and manage internal GMP audits and ensure readiness for customer/regulatory audits.

Handle and oversee market/customer complaint investigations and ensure timely closure.

Review and approve Vendor Qualification and quality-related vendor documentation.

Ensure proper calibration and preventive-maintenance verification of plant and laboratory equipment.





Coordinate with Production, QC, R&D;, Engineering, Warehouse, Procurement and other departments on quality matters.

Review laboratory and manufacturing data and ensure accurate compilation and submission as per customer requirements.

Prepare, review and approve SOPs, protocols, validation documents, training documents and quality records.

Ensure effective implementation and continuous improvement of the Quality Management System.

Train, mentor and supervise QA Executives/Officers and allocate departmental responsibilities.

Ensure timely completion and closure of QA activities, investigations, CAPAs and quality records.

Use and oversee Pharma Cloud/ERP/e-QMS systems for batch and quality-related activities.

Act as the key QA representative during customer, regulatory and external audits.

Drive continuous improvement in quality systems, processes and compliance.

Perform other QA-related responsibilities assigned by management.

📌 Qa Manager Gandhinagar
🏢 Heads Quest
📍 Gandhinagar