全职 QA-QC Executive (NPRA - Regulatory Compliance) 工作, 薪水, Dong Foong Manufacturing Sdn. Bhd. Selangor 公司招聘中 - Ricebowl

Job Highlights

• Specialised focus on NPRA registration, KKM compliance, and health supplement standards.
• Hands-on involvement in product quality assurance, factory QC, and audit readiness.
• Competitive salary package with clear career growth opportunities in contract manufacturing.

Job Responsibilities

• 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.

• 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 (NPRA, JAKIM, ISO, client audits).

Qualifications

• 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.

Requirements

• Strong familiarity with NPRA guidelines (Quest system, Health Supplement registration, classification of food-drug interface products).

• Good knowledge of cGMP, HACCP, Halal (JAKIM), and ISO standards.

• Skills: Excellent attention to detail, strong analytical problem-solving, and good document control management.