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Key responsibilities:
• Lead the Quality Management function across Quality Assurance and Quality Control
• Develop and maintain a robust Quality Management System for the manufacturing site
• Ensure compliance with Thai FDA, GMP, PIC/S and applicable global quality standards
• Act as the site Management Representative for the Quality Management System
• Oversee qualification and validation activities for manufacturing processes and equipment
• Establish quality standards, procedures and specifications for locally manufactured sterile products
• Recruit, develop and lead the site Quality team
• Partner closely with Manufacturing, Supply Chain and other business functions
• Drive process improvements, training and continuous compliance across the facility
Candidate requirements:
• Bachelor's degree in Pharmacy or a relevant scientific discipline
• Valid pharmacist licence would be highly preferred
• More than eight years of experience across Quality Assurance, Quality Control, Regulatory Affairs or related functions
• Strong background within pharmaceutical or medical-device manufacturing
• Good knowledge of Thai GMP, PIC/S requirements and working with relevant health authorities
• Proven experience leading and developing Quality teams
• Excellent written and spoken English, as the position reports to an expatriate regional leader
• Strong capabilities in strategic leadership, stakeholder management, problem-solving and business partnership
Job ID: 151620921