Key Responsibilities

• Oversee end-to-end QA activities including IPQA, documentation, and compliance systems.
• Ensure adherence to GMP, GDP, and company quality policies across production and supporting departments.
• Review and approve GMP documents including SOPs, BMRs, BPRs, protocols, and reports.
• Handle deviations, investigations, CAPA, and change control processes.
• Support internal audits, customer audits, and regulatory inspections (USFDA, WHO, EU GMP).
• Ensure compliance with data integrity principles (ALCOA+).
• Coordinate with Production, QC, Engineering, and Regulatory teams for quality-related activities.
• Monitor quality KPIs and ensure timely closure of quality events.
• Train and guide QA/IPQA team members and production staff on compliance requirements.
• Ensure proper documentation practices and maintain audit readiness at all times.
• Participate in risk assessments and continuous improvement initiatives.
• Support qualification and validation activities (equipment, process, cleaning).