SENIOR QUALITY ASSURANCE & QUALITY CONTROL EXECUTIVE (NPRA)

Dong Foong Manufacturing Sdn Bhd; Semenyih; On-site; MYR 60,000 - 100,000; Full time

Job summary

Dong Foong Manufacturing Sdn Bhd is seeking a Senior QA/QC Executive to drive NPRA registrations, ensure product compliance and lead QC activities. You will manage regulatory dossiers, coordinate audits, and uphold cGMP/HACCP/ISO standards across manufacturing lines.

A hands-on role in QA documentation and CAPA is required for ongoing quality and regulatory excellence. The ideal candidate will have 2–3 years in QA/QC with NPRA experience, and a relevant bachelor’s degree.

Qualifications

• Bachelor’s degree in a scientific field and hands-on QA/QC experience.
• Experience with NPRA product registrations and regulatory dossiers.
• Knowledge of cGMP, HACCP, Halal and ISO standards.

Responsibilities

• Lead NPRA registrations, notifications, and variations with NPRA/KKM.
• Prepare regulatory dossiers including CoA, certificates and validation docs.
• Oversee QC testing: physical, chemical, microbiological parameters.
• Maintain QA documentation and SOPs; conduct CAPA for non-conformances.

Skills

QA/QC

NPRA registration

cGMP

HACCP

ISO 22000

Education

Bachelor's degree in Food Science/Pharma/related

Tools

Quest system

Job description

SENIOR QUALITY ASSURANCE & QUALITY CONTROL EXECUTIVE (NPRA)

We are looking for a motivated QAQC Executive to drive growth in the healthcare sector. This role is ideal for someone with a passion for healthcare client engagement. You will work closely with senior business development managers to identify opportunities, build relationships, and contribute to revenue growth. The role involves specialized focus on NPRA registration, KKM compliance, and health supplement standards, with hands‑on involvement in product quality assurance, factory QC, and audit readiness.

Key responsibilities

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

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)

About you

Bachelor's Degree in Food Science, Food Technology, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline

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

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

Excellent attention to detail, strong analytical problem‑solving, and good document control management

About us

Dong Foong Manufacturing is an established contract manufacturer specializing in high‑quality functional foods, traditional health products, and dietary supplements. We partner with leading brands to deliver safe, effective, and fully compliant healthcare products. Since 2005, Dong Foong Manufacturing factories have been built on a strong foundation based on the highest of quality standards and comply with Good Manufacturing Practice (GMP) principles, JAKIM Halal and Hazard Analysis Critical Control Point (HACCP) standards. With our broad range of services, we drive faster and more efficient development timelines and produce better products through research and development.

Competitive salary package with clear career growth opportunities in contract manufacturing

Dong Foong Manufacturing Sdn Bhd was founded in the year 2005. As part of DF Healthcare Group of Companies, Dong Foong Manufacturing Sdn Bhd focuses in providing OEM manufacturing services for our clients.

Our production line is specialised in the production of traditional herbal capsules, herbal teabags and functional foods.

At Dong Foong Manufacturing, we offer manufacturing services from product innovation, product formulation, raw material sourcing, product packing and labelling.

We also provided services on regulatory affairs which includes registration for MAL, Jakim halal certification and food classification.

Dong Foong Manufacturing Sdn Bhd was founded in the year 2005. As part of DF Healthcare Group of Companies, Dong Foong Manufacturing Sdn Bhd focuses in providing OEM manufacturing services for our clients.

Our production line is specialised in the production of traditional herbal capsules, herbal teabags and functional foods.

At Dong Foong Manufacturing, we offer manufacturing services from product innovation, product formulation, raw material sourcing, product packing and labelling.

We also provided services on regulatory affairs which includes registration for MAL, Jakim halal certification and food classification.