Head Quality Assurance

The ideal candidate should have strong hands-on experience in IPQA, Vendor Qualification, Process Validation, QMS, audits, investigations, CAPA, and change control within a pharmaceutical manufacturing environment.

Key Responsibilities

• Lead and manage the overall Quality Assurance function across manufacturing operations.
• Oversee In-Process Quality Assurance (IPQA) activities and ensure compliance with approved procedures and GMP requirements.
• Plan, execute and review Process Validation / Process Qualification activities.
• Lead Vendor Qualification and Vendor Evaluation, including approval, assessment, audits and periodic re-evaluation of vendors.
• Establish, implement and maintain effective Quality Management Systems (QMS).
• Review and approve SOPs, specifications, protocols, reports, deviations, CAPA, change controls and other quality documents.
• Ensure effective investigation and closure of deviations, incidents, OOS/OOT and market complaints.
• Oversee Batch Manufacturing Record (BMR) / Batch Packing Record (BPR) review and release-related activities.
• Ensure timely implementation and closure of CAPA and Change Controls.
• Coordinate and lead internal, customer and regulatory audits/inspections.
• Ensure compliance with applicable GMP and regulatory requirements.
• Monitor quality trends, identify potential risks and implement preventive actions.
• Work closely with Production, QC, R&D, Engineering, Regulatory Affairs, Supply Chain and other cross-functional teams.
• Drive continuous improvement initiatives related to quality, compliance and manufacturing processes.
• Lead, mentor and develop the QA team to achieve departmental quality objectives.