QA Manager in Ahmedabad, भारत

Position Overview

We are looking for an experienced QA Manager to lead the Quality Assurance function for nutraceutical/pharmaceutical manufacturing operations, with strong exposure to tablets and capsules. The role will own batch documentation, product release, QMS, deviations, CAPA, change control, validation, audits, complaints, vendor qualification, training and QA team management.

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.

Educational Qualification

• https://jobeax.com/link/SmU3RMsPtv68FpzI / https://jobeax.com/link/g8jPrtYeTViWKuvF preferred.
• Candidates with relevant pharmaceutical/nutraceutical QA qualifications and experience may also be considered.

Experience

• 5 - 10 years of relevant experience in Pharmaceutical/Nutraceutical Quality Assurance.
• Strong experience in tablet and capsule manufacturing is preferred.
• Prior experience in QA Manager / Deputy Manager QA / Assistant Manager QA or equivalent senior QA role.
• Experience managing or supervising a QA team.