Senior Microbiologist Job

Date: Jun 12, 2019

Location: Singapore, SG

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Requisition ID: QUA008934

Description




  • 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.


Qualifications

Qualifications 




  • Degree in Microbiology / Biotechnology.

  • 3 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:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Microbiology, Biotech, Engineer, Pharmaceutical, Editor, Science, Engineering, Publishing

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