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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Review batch packaging records and approve for the release of repacked products as per approved standard operating procedures.
Action of On-Hold and Release status of repacked products and printed packaging material (PPM) related to repacking activity in accordance with the approved specifications / procedures.
Perform investigation on reported deviation. Ensure correction and/or corrective action are complete prior to batch release.
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Monitor production quality performance and ensure timely disposition of non-conforming products.\Drive in-process quality control to prevent defects and minimize production disruptions.
Lead investigations into production quality issues and implement effective containment actions.
Conduct and facilitate structured root cause analysis using methodologies such as 8D, 5 Whys, Fishbone Diagram, and FMEA.
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Required to standby on-call for electrical matters or machinery breakdown
Plant Operations & Quality Control: Perform daily operational tasks—including chemical preparation, equipment start-up/shutdown, sampling, and basic troubleshooting—while monitoring processes to ensure product quality specifications are met.
Safety, Compliance & Housekeeping: Adhere strictly to EHS rules, SOPs/WIs, ISO standards (9001 & 14001), and maintain a clean, safe working environment at all times.
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