Develops and establishes quality systems and procedures, inspection plans, quality performance trends, statistical plans, control plan, cost estimates and technical quality plans for proposals;
Ensures that project and/or process control documentation is compliant with requirements and/or contract;
Proposes enhancements and improvements to products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to critical areas of production;
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Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM).
Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements.
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