Quality Assurance Manager

Responsibilities

• Lead and manage the QA department, including team development and performance.
• Ensure compliance with local and international regulatory requirements (e.g. NPRA and PIC / S).
• Oversee Quality Management System including CAPA, deviations, change control etc.
• Work in partnership with Manufacturing, Engineering, and QC to increase knowledge and understanding of cGMPs and improve practices and procedures.
• Serve as the primary contact for regulatory inspections and customer audits.
• To ensure the cGMP compliance in all operational activities for manufacturing of drug products.
• Maintain and update all documents in accordance with statutory / regulatory requirements.
• Ensure all GxP computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.
• Provides appropriate training and development to support staff to meet their respective job responsibilities.
• To execute lot disposition (release or rejection) of Finished Product for distribution.

Qualifications

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