Quality Assurance Manager

Role & responsibilities

• Overall responsibility for GMP compliance and the Pharmaceutical Quality Management System (PQMS).
• Establish, implement, and monitor quality policies, procedures, SOPs, and quality standards.
• Review and approve BMR/BPR, specifications, protocols, reports, and other quality documents.
• Ensure proper handling of deviations, OOS/OOT, CAPA, change controls, and investigations.
• Review and approve batch records and product release as per approved specifications.
• Oversee validation and qualification of processes, equipment, cleaning, and systems.
• Manage market complaints, product recalls, and mock recalls.
• Plan and conduct internal audits and coordinate customer/regulatory inspections.
• Ensure compliance with GMP, GDP, data integrity, and applicable regulatory requirements.
• Monitor vendor qualification and quality agreements where applicable.
• Ensure effective training and GMP awareness of employees.
• Review quality trends, risk assessments, and periodic quality reports.
• Coordinate with QC, Production, Warehouse, Engineering, and Regulatory Affairs on quality matters.
• Promote continuous improvement and a strong quality culture throughout the organization.

Preferred candidate profile

• B.Pharm/M.Pharm/M.Sc. in Pharmacy, Chemistry, or related discipline.
• 15 to 18 years of experience in Pharmaceutical QA, with managerial experience preferred.
• Strong knowledge of GMP, GLP, GDP, Data Integrity, and regulatory requirements.
• Hands-on experience in QMS, deviations, CAPA, change control, OOS/OOT, and risk management.
• Experience in batch release, validation, audits, inspections, and product complaints/recalls.
• Strong leadership, decision-making, analytical, and problem-solving skills.
• Excellent documentation, communication, and team-management skills.
• Ability to ensure regulatory compliance and continuous quality improvement.