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Microbiology Manager Job Singapore,  


Posted on : 10 April 2017

Project Description

Microbiology Manager-QUA005341Description- 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.MAIN RESPONSIBILITIES- 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.ACCOUNTABILITIES- 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.Qualifications- 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 ControlPrimary Location: APAC-SG-Singapore-SingaporeEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Microbiology, Biotech, Law, Marketing Manager, Pharmaceutical, Science, Legal, Marketing

Locations

Singapore, SG

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