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Jobs or company...

Senior Laboratory Technician, Quality Control (6 Months Contract)

Salary undisclosed

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JobStreet
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JOB PURPOSE

  • Assist the Senior Executive, Quality Control to manage and execute laboratory operations for pharmaceutical products in Quality Control Laboratory.
  • Monitor and ensure that all sampling and testing of raw materials, packaging materials, in-process and finished products are carried out on a timely basis.
  • Ensure strict adherence to laboratory compliance with PIC/S cGMP (current Good Manufacturing Practice), ISO (9001, 13485 and 17025) and SHE (Safety, Health, & Environment) requirements.

KEY ACCOUNTABILITIES

  • Coordinate and execute sampling and testing on packaging materials, raw materials, in-process (IPQC), and finished products (FPQC) on a timely basis.
  • Perform analytical microbiological testing such as microbial contamination tests, sterility tests, heparin assays, etc. according to the protocol and specifications.
  • Perform the support microbiological testing such as media preparation, growth promotion tests, container closure integrity tests, microbial identification tests, etc. according to the protocol and specifications.
  • Conduct method validation, verification, and transfer activities for the analytical test methods as per the agreed timeline.
  • Develop and maintain standard operating procedures, test protocols, work instructions and other documents related to the Microbiology Section according to the guidelines.
  • Monitor and execute laboratory instrument calibration, internal verification and maintenance to comply with its requirements.
  • Conduct training and assess team members’ performances in handling their routine work in compliance with PIC/S (cGMP), ISO and SHE guidelines.
  • Maintaining laboratory compliance and housekeeping according to PIC/S cGMP, ISO, SHE and other related requirements in Microbiology Laboratory.
  • Check, review and approve microbiological testing reports conducted by Microbiology Lab personnel, when required.
  • Ensuring all reagents, chemicals, consumables and disposables used for the Microbiology Laboratory are well-equipped.
  • Responsible for sample arrangement in QC retention rooms.
  • Support environmental and utilities monitoring (sampling and testing) when required.

JOB REQUIREMENT

  • Must possess at least a Bachelor degree in biological sciences e.g. Microbiology, Biochemistry, Biotechnology or equivalent
  • Minimum of 1 year of working experience in a laboratory environment.
  • Knowledge of cGMP and ISO (9001 and 17025) are required.
  • Microbiological testing for pharmaceutical products and handling laboratory instruments are essential.
  • Analytical skills and must be well-versed in documentation.
  • Good understanding of scientific and technical data.
  • Result-oriented, self-motivated, good team player and self-confident are the behavior required.
  • Ability to communicate effectively to all levels of employees, good presentation skills.
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