Work closely and actively with factories on damage stocks improvement related dented, torn and other defects noted on arrival of stocks at IMS warehouse.
Participate actively in WOR with relevant stake holders to discuss and share on IMS related issues or topics.
Work closely with Post Documentation Team to ensure timely signature on Certificate of Analysis and other technical documents required for export shipments.
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NPRA & Regulatory Compliance: 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. Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Quality Assurance & Quality Control (QA/QC): Oversee daily QC testing (physical, chemical, and microbiological parameters) for raw materials, packaging materials, in-process samples, and finished products. Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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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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Attend site meetings and coordinating with contractors and consultants. Participate in factory acceptance tests, site acceptance tests, and overall testing and commissioning procedures for M&E systems to ensure functionality and safety.
Promote safety awareness on site and ensure that all M&E work practices comply with health, safety, and environmental regulations.
To verify site progress reports/documents submitted by the contractor.
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