QA/QC Executive

Dong Foong; Semenyih; On-site; MYR 78,000 - 134,000; Full time

Benefits offered by this job

EPF & SOCSO

Annual Bonus

Annual Leave

Medical and Hospitalisation Leave

Job summary

Jora Malaysia is seeking a QA/QC and NPRA regulatory specialist to manage product registrations, variations, and dossiers for pharmaceutical, health supplement, and functional food products.

You will oversee QA/QC testing, ensure compliance with NPRA/KKM, cGMP, HACCP, ISO standards, and act as the primary liaison with external regulators and internal teams.

Qualifications

• Bachelor’s degree in a scientific discipline as listed.
• 2–3 years hands-on QA/QC and NPRA registration experience in pharma/health supplement/functional foods.
• Familiarity with NPRA guidelines, Quest system, Health Supplement registration, and food-drug interface classification.

Responsibilities

• Lead and coordinate product registration, notifications, and variations with NPRA/KKM.
• Prepare, review, and organize regulatory dossiers including CoA, ingredient validation, and submissions.
• Ensure raw materials, formulations, and labeling meet NPRA/KKM requirements.
• Serve as main contact for regulatory authorities and internal teams on regulatory matters.
• Oversee QA/QC testing of raw materials, in-process samples, and finished products.
• Maintain QA documentation including SOPs and product specifications; conduct RCA and CAPA for non-conformances.

Skills

Attention to detail

Analytical skills

Document control

Education

Bachelor’s degree in Food Science/Technology/Pharmacy/Biotechnology/Chemistry or related

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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.

Requirement

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.

Responsibility

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.

Benefits

• EPF & SOCSO
• Annual Bonus
• Annual Leave
• Medical and Hospitalisation Leave