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Microbiologist / Senior Microbiologist Job - Singapore  

MSD (company)


Posted on : 22 April 2017

Project Description

Microbiologist / Senior Microbiologist-QUA004684Description- 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, LABIn 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 activitiesJob: Quality Lab Related Job Title:Microbiologist / Senior MicrobiologistPrimary Location: APAC-SG-Singapore-SingaporeEmployee Status: RegularTravel: NoCompany Trade Name:MSD Job Segment: Microbiology, Biotech, Engineer, Pharmaceutical, Laboratory, Science, Engineering

Locations

Singapore, SG

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