- To support and supervise a group of Senior, Lead I Microbiologists and coordinate microbiological testing and associated resource needs on day to day basis for Microbiology Laboratory that supports the sterile operation within Biotech facility or non-sterile operation within API (West and South), DPI, Pharmaceutical (West and South), and R & D facilities.
- Participates in drug product and drug substance analytical development and testing support for all late stage and marketed drug candidates manufactured in MSD Singapore as required.
- Support the generation of CMC information for IND amendments and regulatory filings to support marketing approvals as required.
- Supervise a group of Senior, Lead I Microbiologists.
- Lead daily Tier 1 board to provide testing status updates and highlight quality and safety issues for Microbiology Lab.
- Support and provide technical information pertaining to microbiological tests to lab management on routine basis.
- Review and approve test reports log books, data sheets that are generated in microbiology lab.
- Review SOPs and Protocols with relevant to Microbiology.
- Review compendia! and other site and corporate policy changes and ensure necessary change control for lab SOPs.
- Participate in trouble shooting activities for Utility systems and clean rooms.
- Conduct investigations for OOS and OOG results.
- Approve/Authorize additional testing/re-testing/re-sampling as appropriate, based on review of test results, Lab investigation Reports & I or cross functional investigation.
- Participate in cross functional investigation and other relevant forum to represent Microbiology section.
- Coordinate in Method Transfer, Validation studies and Method Qualification Studies.
- Participate/co-ordinate in Internal Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.
- Coordinate with Senior Manager in performing periodical appraisal of Microbiologists.
- Coordinate with Senor Manager in planning and operation of the Department.
- Oversee the Calibration and Preventive Maintenance Programme.
- Ensure completion of periodic reviews of SOPs.
- Promote Cl culture in the area to ensure sufficient and objective practices.
- Develop and manage a competency based training program for all Microbiology lab staff and provide coaching and mentoring for staff's personal and professional development.
- Participate in SHE, Business Compliance, cGMP and other compliance related matters, where applicable.
- Review & approve FECC raise with respect to microbiological impact.
- Supervise and oversee Third party Contractors, where applicable.
- Any other tasks as and when assigned by Senior Manager.
- Liaise with other department on planning and related testing.
- Liaise with other MSD sites regarding Method transfers, Technology Transfers and other activities.
- Liaise with vendors, services engineers/ESPs for equipment validation, calibration and maintenance work.
- Any other duties as assigned by the Senior Manager I Director.
- Analytical support in commercial supply of drug substances and drug products for Microbiology Laboratories MSD Singapore site.
- Analytical support in development, clinical and other related commercialization activities.
- Other relevant activities as described in the Main responsibilities section.
- Bachelor of Science or related engineering degree.
- Minimum 7 years relevant experience in the pharmaceutical industry.
- Experience with pharmaceutical production process/demonstrated record of investigation analysis/analytical laboratories is highly desirable.
- Good knowledge of cGMP, ICH and regulatory guidelines associated with stability, equipment qualification and QA oversight of validation activities.
- Good technical understanding and judgment.
- Good interpersonal and communication skills
- Team player with ability to work in cross functional teams as well as independently depending on the requirement of task in hand
- Analytical development mindset in research and commercialization activities.
Job: Quality Lab Related Job Title:Mgr, Quality Control
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Microbiology, Biotech, Law, Marketing Manager, Pharmaceutical, Science, Legal, Marketing