Quality Assurance Manager

2 days ago

Sungai Petani, Kedah, Malaysia BTI Executive Search Pte Ltd Full time 120,000 - 180,000 per year

Key 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:


• Bachelor's or Master's degree in Pharmacy, Chemistry, or related field.


• 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership role.


• Strong knowledge of GMP, ICH guidelines, and regulatory frameworks.


• Proven track record in managing audits and regulatory inspections (NPRA).


• Excellent leadership, communication, and problem-solving skills.


• Proficient in power point presentation.

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