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Microbiologist
2 months ago
Job Description THE OPPORTUNITY Be part of the team that ensures sustainable products meet standard quality and are committed to delivering to customers worldwide Based in Singapore , the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023). Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Quality Control (QC) Microbiology is part of our Manufacturing Division, where we ensure that safe and efficacious medicines and consumer healthcare products are delivered to patients around the world every day through accurate and reliable testing services. WHAT YOU WILL DO As part of the QC Microbiology team in Singapore, Microbiologists and Analysts also qualify competent employees to perform precise sampling to monitor the quality of the facility's critical systems, such as water systems and cleanrooms to meet pharmaceutical grade waters and classifications for its intended manufacturing use. The data generated from the laboratory is analyzed by the Microbiology department and is valuable in supporting the Manufacturing Division for decision making and sharing for other network sites to leverage on. This position reports to the Manager in the Microbiology Laboratory of the company's Biotechnology Facility. Main responsibilities include: 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 routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas, and labs, inclusive of particle monitoring tests. Perform personnel qualification and re-qualification, lead qualification and re-qualification of the clean rooms, when necessary. Provide testing support to plant validation activities. Perform in-process and release sample testing of excipient/packaging components for different drug products, semi-finished drug products, and drug substances (e.g., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc.). Perform routine and Batch-related Environmental monitoring in clean rooms and other production areas and laboratories. Perform Media receival, Sterility check, and Growth Promotion Tests for media used in 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 reviews. Writing/revision of SOPs, protocols, test reports, and any other work assigned by the Senior/Lead Microbiologist, Senior/Manager, Microbiology. Liaise with external vendors on instrument calibration and maintenance. Solicit quotations for laboratory consumables. Maintain continuous supply of laboratory consumables. Participate in EHS, Business Compliance, c GMP, and all other compliance-related matters, where applicable. Supervise and oversee Third Party Contractors, where applicable. Coordinate with Quality, respective Plant Operations, Projects, and Engineering & Maintenance. Liaise with other departments for training needs and technical support. Liaise with vendors and service engineers for equipment validation, calibration, and maintenance work. Coordinate with suppliers of microbiological media and other equipment. Any other duties assigned by the Manager. WHAT YOU SHOULD HAVE Qualifications: • Degree in Microbiology / Science (general) / related Engineering field Required Skills / Experience / Competencies: • Good understanding of Safety and c GMP practices • Computer Literacy • Good oral and written communication skills WHAT YOU CAN EXPECT Limitless opportunities across various areas in Manufacturing; well-structured career path A state-of-the-art facility that delivers solutions to its customers worldwide We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. #J-18808-Ljbffr
