Formulator cum QC

SM Health Care Sdn. Bhd.; Kimanis; On-site; MYR 67,000 - 100,000; Full time

Job summary

SM Health Care Sdn. Bhd. is seeking a Formulator QC to ensure quality control and regulatory compliance of cosmetic and combination product formulations across the lifecycle. The role bridges formulation science with QC, ensuring products meet specifications and GMP standards (ISO 22716) and ISO 13485 where applicable.

You will oversee raw material testing, in-process QC, finished product testing, batch review, stability studies, deviation handling, CAPA, and regulatory filing support.

Qualifications

• Bachelor's degree in a chemical-related field with focus on cosmetics or pharma QC.
• Knowledge of ISO 22716 Cosmetic GMP and ISO 13485 regulatory requirements.
• Experience in QC/formulation within cosmetics, pharma, or medical devices.

Responsibilities

• Inspect and test incoming actives, excipients & packaging components against approved specs.
• Review CoA and SDS; support supplier qualification and material changes.
• Verify in-process QC parameters and flag deviations in real time.
• Perform microbiological testing, packaging compatibility checks, and label verification.
• Review batch records, release or reject batches, and maintain records per ISO standards.
• Design and monitor stability studies; update shelf-life claims based on data.
• Lead deviation investigations, CAPA, and change control; assess impact of changes.

Skills

Quality control

Regulatory compliance

GMP awareness

Education

Bachelor's in Chemistry

Cosmetic Science

Pharmacy

Chemical Engineering

Related field

Job description

The Formulator QC is responsible for the quality control and compliance verification of formulated products (cosmetic and/or combination medical device products) throughout the product lifecycle — from raw material qualification through in-process testing to finished product release. This role bridges formulation science and quality control, ensuring formulations meet defined specifications, regulatory requirements, and are manufactured under conditions compliant with ISO 22716 (Cosmetic GMP) and, where applicable, ISO 13485 (Medical Device QMS) for any combination or device-classified products.

Key Responsibilities

1. Raw Material & Incoming QC

Inspect and test incoming actives, excipients & packaging components against approved specs

Review Certificates of Analysis (CoA) and Safety Data Sheets (SDS)

Support supplier qualification and raw material change assessments

2. In-Process QC

Verify critical process parameters (temperature, mixing time, pH adjustment) against master formula

Flag and elevate deviations in real time

3. Finished Product Testing

Microbiological testing: total microbial count, preservative efficacy (challenge testing)

Packaging compatibility and label verification

4. Batch Review, Release & Documentation

Review batch manufacturing records against approved master formula

Approve or reject batches based on QC results

Maintain Device History Records (ISO 13485) and Product Information Files (ISO 22716)

Retain samples & reference standards per protocol

5. Stability & Shelf-Life Management

Design and monitor accelerated (40°C/75%RH) and real-time stability studies

Assess compatibility with primary packaging over shelf life

Update expiry/shelf-life claims based on data trends

6. Deviation, CAPA & Change Control

Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results

Lead root-cause analysis (5-Why, fishbone) for recurring quality issues

Initiate and track Corrective and Preventive Actions (CAPA)

Assess quality impact of formulation, process, supplier or specification changes

7. Regulatory & Audit Compliance

Ensure alignment with ISO 22716 clauses: personnel, premises, equipment, production, QC lab, complaints

For combination/device products, ensure traceability & risk management (ISO 14971 linkage) per ISO 13485

Support technical file compilation for regulatory submissions (CE marking, ASEAN Cosmetic Directive, FDA, MDR)

Prepare for and participate in internal/external audits & certification renewals

Develop and validate analytical test methods for new formulations

Ensure lab equipment calibration & maintenance schedules are followed

Qualifications

Education: Bachelor's in Chemistry, Cosmetic Science, Pharmacy, Chemical Engineering, or related field

Experience: 2–5 years in QC/formulation within cosmetics, pharma, or medical device manufacturing

Regulatory Knowledge: ISO 22716 (required); ISO 13485 & ISO 14971; ASEAN Cosmetic Directive, EU 1223/2009, FDA OTC/cosmetic rules, MDR/IVDR as applicable