Supervisor, Quality Control

2 weeks ago


Shah Alam, Selangor, Malaysia Duopharma (M) Sdn Bhd Full time
1.

Conduct microbiological tests for raw materials, in process finished products, finished products, and environmental monitoring to ensure conformance with appointed quality standards and specifications from latest pharmacopeia.


  • Assist in conducting method validation of microbial testing for finished products and update the test methods according to the current pharmacopeia.
  • Assist in updating and completing QC documentation especially in microbiology and GLP related documents.
  • Conduct microbiological routine tests on raw materials, in process finished products, and finished products according to the established test protocols and SOPs.
  • Conduct environmental monitoring for HVAC AHU in Production Containment and Microbiology Lab areas
  • Conduct environmental monitoring for compressed air at the Production containment area
  • Sampling and testing Purified Water System at DHAPI plant
  • Prepare the media for use in environmental monitoring, microbial testing, and PWS monitoring
  • Identify the microbial species isolated from environmental and PWS monitoring.
  • Monitor the scheduled waste produced from micro lab and dispose according to schedule waste SOP.
  • Assist GLP in liaising with vendor in requesting the quotation for the consumable used in micro lab.
  • Assist in keeping up the microbiological laboratory practice and documentation in accordance to the latest GMP and GLP requirements.
  • Ensure the inventory of microbiological laboratory is available and sufficient at all times to avoid any delay in microbiological testing.
  • Assist in executing Validation and Qualification activities related to microbiological testing as per details in protocols and reporting the results immediately with minimum delay time prior to the project timeline.
  • Assist GLP routine such as performing balance performance verification, recording DP, temperature & humidity in Micro lab.
  • Assist in Validation Test such as MCT method validation and performance qualification.
  • Assist in issuing microbial and GLP reports such as MCT, EM, Balance Performance, Autoclave verification reports.
  • Assist in QC documentation such as update SOP, issue incident report, CAPA, and Deviation documentation.
  • Report to superior on any deviations from normal quality controls standards.
  • Assist in the general maintenance of the laboratory cleanliness and safety in adhering to company's policy.
  • Complete other relevant duties and responsibilities assigned by superior.

Requirements:

Experience:

Min Diploma in any Science Discipline

Fresh graduates are welcome. With experience is advantageous.

Familiar with microbiological testing method

Well versed in analytical, problem-solving and communication skills.

Intermediate knowledge of cGMP, GLP and laboratory instruments.

Good Microbiology laboratory skills.

Salary:
RM2, RM3,350.00 per month

Benefits:

  • Dental insurance
  • Health insurance
  • Parental leave
  • Vision insurance

Schedule:

  • Day shift

Supplemental pay types:

  • Yearly bonus

Ability to commute/relocate:

  • Glenmarie Industrial Park: Reliably commute or planning to relocate before starting work (required)

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