Cell Production Executive

  1. Perform production operations including isolation, thawing, expansion, harvesting, cryopreservation and releasing to ensure the product is processed, preserved and distributed under aseptic conditions in accordance with the requirement of the cGMP regulation.
  2. Execute production activities as per approved Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs).
  3. Maintain cleanroom behavior and gowning compliance in classified areas.
  4. Monitor critical process parameters and record data accurately in accordance with ALCOA+ data integrity principles.
  5. Ensure proper handling, usage, and traceability of raw materials, media, and reagents.
  6. Operate and maintain production equipment.
  7. Be involved in maintaining accurate documentation related to inventory bookkeeping and equipment usage, calibration, and maintenance records, ensuring compliance with GMP, ISO and data integrity requirements.
  8. Conduct in-process checks and collaborate with Quality Assurance / Quality Control to ensure process compliance.
  9. Participate in deviation reporting, CAPA implementation, and change control processes.
  10. Support validation, technology transfer, and process optimization initiatives.
  11. Ensure compliance with PIC/S GMP, ISO, EHS regulations, and company quality standards always.
  12. Coordinate procurement of reagents and consumables, including raising purchase requests, and ensuring timely availability of materials for production.
  13. Liaise and communicate with vendors or suppliers regarding quotations, lead times, order status, and product quality issues when necessary.
  14. Attend adequate training sessions prior to performing any assigned tasks or whenever required.
  15. In the absence of an Immediate Superior, the Executive shall take over relevant responsibilities under the supervision of Management to ensure smooth operations.
  16. Actively participate in the meeting and discussion related to production issues.
  17. Undertake other relevant duties assigned by Management, as necessary.
Pay: RM3,000.00 - RM4,000.00 per month

Work Location: In person

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