Accurately document the results of the inspections on-timely manner.
Collect and send the samples to QC laboratory on-timely manner.
Responsible in reporting immediately to QC Executive/HOD any deviation or abnormalities detected in-process and daily monitoring process in manufacturing facilities
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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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• Implement site QAQC requirements for E&I EPCC rejuvenation / brownfield works in accordance with the Project Quality Plan, ITPs, method statements, approved drawings, specifications and client requirements.
• Coordinate inspection hold / witness points and ensure required inspections are accepted before subsequent work proceeds.
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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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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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