Singapore Job Openings
Lonza
Analyst (BioChemistry), QC
Tuas
FULL TIME
October 8, 2024
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The QC Analyst will be responsible for Biochemistry Area in the QC Lab to support Lot Release activities
Responsibilities
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Prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
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Analysis of final product, in-process, stability samples according to Standard Operating Procedures and Test Methods.
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Documentation and review of results in accordance with current Good Manufacturing Practices (c GMP).
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Understanding and execution of methods which may include ELISA, PCR, CE, SDS-PAGE, IEF, ic IEF, potency methods, and other physiochemical methods.
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General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
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Prepare, maintain standards and reagents as required by GMP documents.
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Responsible to follow data integrity requirements.
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Actively contributes to operational efficiency/continuous improvement initiatives.
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Problem solving of analytical methods as well as troubleshooting of equipment.
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Involved in equipment qualification, maintenance and troubleshooting.
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Support / Perform OOS, deviation investigations. Draft investigations reports.
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Be a trainer for test method.
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Involvement in method transfers and validation.
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Author Change Controls, Test Methods, SOPs.
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Lead Out-Of- Specifications (OOS) and deviation investigations.
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Diploma / Degree or higher from recognized institution with at least 3 years’ experience in Quality unit in the Biopharmaceutical industry
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Relevant work experience preferably Lab experience in a biotech or medically related field
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Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICH Guidelines)
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Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
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Is willing to take on new challenges
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Good interpersonal skills
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Effective Communicator (oral and written)
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Plans, prioritizes and organizes work to deliver on time
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Exhibit good quality decision making traits
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Meticulous and Systematic and Analytical Mind
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Team player who can operate independently, with strong focus on safety, quality and timelines
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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