Senior Executive, Biochemist

2 weeks ago

Puchong New Village, Malaysia Pharmaniaga LifeScience Sdn Bhd Full time 80,000 - 120,000 per year

  1. To perform sampling of starting materials (APIs and excipients), packaging materials (rubber closures), in-process products, finished products and utilities (water, pure steam and nitrogen) according to sampling instructions and other Quality Control procedures.

  2. Perform bioanalytical testing on incoming and finished products such as ELISA, reverse-phase HPLC, size exclusion HPLC, etc. for biological products in accordance with the test procedure and specifications. Participate in analytical method transfer exercise (AMTE) between technical partner and PLS laboratories.

  3. To write and revise/update Standard Operating Procedures (SOP), Specification, Standards Test Procedures (STP), Testing Procedures (TP) and Work Sheet (WS) for Biochemistry Laboratory.

  4. To conduct the required training such as GMP to laboratory personnel.

  5. To review and accurately report test results and data; to conduct investigations into any test results that are out of trend (OOT) or out of specification (OOS), in accordance with the Quality System.

  6. To safeguard and ensure that all documents related to OOS and OOT investigations are properly stored, maintained, and readily retrievable as per documentation control procedures.

  7. To maintain laboratory record and responsible for safe keeping of all documentations relating to testing eg: preparation of media, culture maintenance, growth promotion test.

  8. To purchase Biochemistry Laboratory assets and consumables (CAPEX and OPEX).

  9. To assist on the laboratory equipment qualification (IQ/OQ/PQ) and JKKP inspection.

  10. To review and manage the calibration and maintenance of laboratory equipment.

  11. To ensure records of equipment usage and other activities log sheets are updated and reviewed accordingly.

  12. To ensure proper segregation, recording and storage of all wastes related to Biochemistry Laboratory.

  13. To ensure temperature and relative humidity monitoring in the laboratory and related equipment are conducted as per SOP and record are updated.

  14. To monitor changes within the regulatory environment and pharmacopoeia requirement with a view to reporting status of the quality systems to the management team and implement new quality initiatives and strategies.

  15. To check and ensure laboratory hygiene and operate to GLP e.g.: cleaning, housekeeping and labeling.

  16. To keep adherence to Good Manufacturing Practice (GMP), ISO 9001, ISO 14001, ISO 45001 and ISO 17025.

  17. To achieve compliance with HALAL requirements, ISO requirements such as ISO 9001, ISO 14001, ISO 45001, ISO 17025, cGMP and GDP requirements such as PIC/S, US-FDA, EU-GMP, EU-GDP, local regulatory and third-party principal requirement.

  18. To undertake any other duties as directed by the immediate supervisor and Management as and when required.

Job Types: Full-time, Permanent

Pay: RM2, RM5,500.00 per month

Work Location: In person

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