QA / QC Manager

Job Title: QA Manager (Quality Assurance)Industry: Pharmaceutical

Job Summary:The QA Manager is responsible for overseeing all quality assurance activities to ensure compliance with regulatory standards such as GMP, GLP, and relevant guidelines. The role ensures that pharmaceutical products are manufactured, tested, and released in compliance with quality standards and regulatory requirements.

• Key Responsibilities:Lead and manage the Quality Assurance department.
• Ensure compliance with GMP (Good Manufacturing Practices), WHO, USFDA, and other regulatory standards.
• Review and approve:
• Batch Manufacturing Records (BMR)
• Batch Packaging Records (BPR)
• Standard Operating Procedures (SOPs)
• Handle deviations, CAPA (Corrective and Preventive Actions), and change control.
• Conduct internal audits and coordinate regulatory inspections.
• Oversee validation activities:
• Process validation
• Cleaning validation
• Equipment qualification (IQ/OQ/PQ)
• Ensure proper documentation and data integrity (ALCOA+ principles).
• Manage product complaints, investigations, and recalls if required.
• Collaborate with production, QC, and regulatory affairs teams.
• Train and mentor QA team members.
• Monitor and improve quality systems and processes.