全职 Head of Quality Assurance 工作, 薪水, Malaysian Pharmaceutical Industries Sdn. Bhd. Pulau Pinang 公司招聘中 - Ricebowl

Company Description Malaysian Pharmaceutical Industries Sdn. Bhd. is an established generic drug manufacturer in Malaysia with a focus on unique products, including antipsychotic and psychotropic medications, Calcium Carbonate, and cephalosporin antibiotics. The company operates a specialized manufacturing facility designed in accordance with PIC/S (Pharmaceutical Inspection Co-operation Scheme) requirements. This commitment to international standards supports consistent product quality and regulatory compliance. Team members join a regulated environment that emphasizes patient safety, reliable supply, and continuous improvement in pharmaceutical manufacturing.

Role Description The Head of Quality Assurance is a full-time, on-site role based in Bayan Lepas. This position is responsible for leading the Quality Assurance function, ensuring compliance with PIC/S, GMP, and relevant national and international regulatory requirements. Daily responsibilities include overseeing quality systems, approving SOPs and validation protocols, reviewing and releasing batches, managing deviations, CAPA, change controls, and leading internal and external audits. The role also involves collaborating with Production, Quality Control, Regulatory Affairs, and Supply Chain to maintain product quality, resolve quality-related issues, and support continuous process improvement. The Head of Quality Assurance will mentor, train, and develop the QA team, promote a strong quality culture, and provide quality-related reports and recommendations to senior management.

Qualifications

• Strong Quality Assurance and Quality Management skills, including oversight of quality systems, documentation, and compliance activities.
• Proficiency in Quality Control practices with the ability to coordinate with QC laboratories and interpret quality-related data.
• Experience in Quality Auditing, including planning and conducting internal audits and managing regulatory and customer inspections.
• Well-developed Analytical Skills for evaluating trends, investigating root causes, and implementing effective corrective and preventive actions.
• Extensive experience in pharmaceutical manufacturing, preferably in generic drug production under PIC/S or GMP frameworks.
• Bachelor’s degree or higher in Pharmacy, Pharmaceutical Science, Chemistry, or a related scientific discipline.
• Demonstrated leadership capabilities, including team management, coaching, and cross-functional collaboration.
• Strong communication and reporting skills, with the ability to present quality issues and improvement plans to stakeholders.
• Detail-oriented, organized, and able to manage multiple priorities in a regulated environment.
• Familiarity with regulatory guidelines from relevant health authorities and international standards bodies.