Quality Control Executive

Dong Foong; Semenyih; On-site; MYR 65,000 - 90,000; Full time

Benefits offered by this job

EPF & SOCSO

Annual Bonus

Annual Leave

Medical and Hospitalisation Leave

Job summary

Jora Malaysia seeks a Regulatory QA/QC specialist to drive NPRA product registrations and ensure regulatory compliance across pharmaceutical, health supplement, and functional food manufacturing. You will coordinate NPRA submissions, maintain cGMP/HACCP/ISO standards, and ensure proper documentation and audits.

Ideal candidate has 2–3 years QA/QC/NPRA experience, strong analytical skills, and meticulous attention to detail, with ability to liaise with external authorities and internal teams.

Qualifications

• Bachelor’s degree in a scientific discipline as listed.
• Minimum 2–3 years hands-on QA/QC and NPRA product registration experience.
• Familiarity with NPRA guidelines, Quest system, Health Supplement registration, and food-drug interface classifications.
• Knowledge of cGMP, HACCP, Halal (JAKIM), and ISO standards.

Responsibilities

• Lead and coordinate product registration, notifications, and variations with NPRA/KKM.
• Prepare, review, and organize regulatory dossiers including CoA, ingredients validation, etc.
• Ensure raw materials, formulations, and labeling meet NPRA and KKM requirements.
• Serve as main contact for regulatory authorities and internal teams on regulatory matters.
• Establish and maintain QA documentation (SOPs, CoA, BPR, product specs).
• Support internal and external audits for NPRA, JAKIM, ISO, and clients.

Skills

QA/QC

Regulatory knowledge

Documentation

Analytical skills

Attention to detail

Problem solving

Education

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

Tools

CoA management

BPR documentation

Dossier preparation tools

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.

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