QA-QC Executive (NPRA - Regulatory Compliance)

Dong Foong; Shah Alam; On-site; MYR 60,000 - 90,000; Full time

Job summary

Dong Foong in Malaysia seeks a QA-QC Executive to manage NPRA regulatory compliance and health supplement registration, ensuring submissions and labeling meet NPRA/KKM standards.

You will oversee QA/QC testing, maintain SOPs and CoA records, support audits, and ensure cGMP, HACCP, ISO 22000, and Halal compliance across manufacturing. This is an on-site role with growth in contract manufacturing.

Qualifications

• Bachelor's degree in a related scientific discipline and 2-3 years of QA/QC/NPRA registration experience.
• Familiar with NPRA guidelines, Quest system, and Health Supplement registration.
• Knowledge of cGMP, HACCP, Halal (JAKIM), and ISO standards; strong documentation skills.

Responsibilities

• Lead and coordinate NPRA registration, notifications, and variations with NPRA/KKM.
• Prepare, review, and organize regulatory dossiers and required documents.
• Ensure compliance of raw materials, formulations, and labeling with NPRA/KKM.
• Oversee QA/QC testing (physical, chemical, microbiological) and maintain QA records.
• Support internal and external audits and implement CAPA for non-conformances.

Skills

Analytical skills

Attention to detail

Problem solving

Document control

Education

Bachelor's Degree in Food Science / Food Technology / Pharmacy / Biotechnology / Chemistry

Tools

NPRA Quest system

SOPs

CoA management

Job description

Jora Malaysia will close on 16th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

QA-QC Executive (NPRA - Regulatory Compliance)

• Specialized 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).

Job Requirements

• 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 (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.