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Microbiologist / Senior Microbiologist Job

Date: Nov 15, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: QUA004684

  • Support testing/ monitoring functions pertaining to aseptic manufacturing and microbiological testing of Raw materials, Excipient, In-process materials, semi finished and finished products manufactured in the API, DPI, Biotech, Tablets and R&D facilities.
  • Responsible for testing of developmental and clinical products as required.
  • Participate in analytical developmental activities as required.

MICROBIOLOGIST, LAB
  • Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. Compressed air and Nitrogen systems.
  • Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test.
  • Perform personnel qualification and re-qualification and also to lead qualification and re-qualification of the clean rooms, when necessary.
  • Provide testing support to plant validation activities
  • Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate.
  • Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
  • Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
  • Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
  • Perform microbial identification (Bacteria, mold and yeast) in water, environment and product samples.
  • Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
  • Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior, Lead Microbiologist, Sr/ Manager, Microbiology.
  • Liaise with external vendors on instrument calibration and maintenance.
  • Solicit quotations of laboratory consumables.
  • Maintain continuous supply of laboratory consumables
  • Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
  • Supervise and oversee Third Party Contractors, where applicable.
  • Need to co-ordinate with Quality, respective Plant Operations, Projects and Engineering & Maintenance.
  • Liaise with other department for training needs and technical support
  • Liaise with vendor and service engineers/ESPs for equipment validation, calibration and maintenance work.
  • Need to coordinate with suppliers of microbiological media and other equipment.
  • Any other duties as assigned by the Supervisor / Manager.

SENIOR MICROBIOLOGIST, LAB

In addition to the responsibilities of MICROBIOLOGIST, LAB:
  • Perform method transfers/Qualifications for drug substances and other drug products.
  • Maintain the Calibration and Preventive Maintenance Programme.
  • Review of compendial and corporate policy changes.
  • Prepare trend Reports.
  • Perform Qualification and validation of equipment.
  • Review and approve test reports log books, data sheets that are generated in microbiology lab.
  • Review SOPs and Protocols with relevant to Microbiology.
Qualifications

  • Degree in Microbiology / Biotechnology.
  • 0 to 6 years’ experience in pharmaceutical industry is preferred.
  • Previous OJT is preferred
  • Good understanding of Safety and cGMP practices
  • Computer Literacy
  • Experience in operating laboratory equipment and lab computer systems is very desirable.
  • Good oral and written communication skills.
  • Analytical development mindset in research and commercialization activities


Job: Quality Lab Related
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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