- 28, Jalan Hi-Tech 6/1, Kawasan Perindustrian Hi-Tech 6 Semenyih Selangor Malaysia 43500

工作地点
职位描述
任职资格
Education
Bachelor’s Degree in Food Science, Food Technology, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline.
Experience
Minimum 2–3 years of hands-on experience in QA/QC and NPRA product registration within the pharmaceutical, health supplement, or functional food manufacturing industry.
Knowledge
Strong familiarity with NPRA guidelines, including Quest system, Health Supplement registration, and classification of food-drug interface products.
Good knowledge of cGMP, HACCP, Halal (JAKIM), and ISO standards.
Skills
Excellent attention to detail.
Strong analytical and problem-solving skills.
Good document control management skills.
岗位职责
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, including 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) (Halal)
Oversee daily QC testing for 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.
Conduct root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA) for non-conformances, customer complaints, or out-of-specification (OOS) test results.
Ensure strict adherence to cGMP, HACCP, ISO 22000, and Halal standards across manufacturing lines.
Facilitate internal quality audits and support external audit preparation for NPRA, JAKIM, ISO, and client audits.
好处
重要安全守则
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