1 день назад
Analyst, Quality Control (Biopharmaceuticals)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst, Quality Control (Biopharmaceuticals): Performing biochemistry testing for lot release, final products, in-process and stability samples with an accent on GMP compliance, data integrity, and analytical assay execution. Focus on troubleshooting methods and equipment, leading OOS and deviation investigations, and contributing to method transfer, validation, and equipment qualification.
Location: SG - Tuas, Singapore
Company
is a global life sciences company manufacturing medicines across more than 30 sites on five continents.
What you will do
- Prioritize and perform biochemistry testing to support lot release and business timelines.
- Test final product, in-process, and stability samples according to SOPs and approved methods.
- Execute ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical assays.
- Document and review results in compliance with cGMP and data integrity requirements.
- Maintain laboratory operations, including equipment upkeep, inventory, autoclaving, glassware management, and reagent preparation.
- Troubleshoot analytical methods and equipment, support qualification and maintenance, investigate OOS results and deviations, train colleagues, and author change controls, test methods, and SOPs.
Requirements
- Degree or higher with 5 years of QC or quality experience in biopharmaceuticals.
- Laboratory experience in biotechnology or medically related fields is preferred.
- Familiarity with FDA, EMEA, and ICH guidelines and GMP quality systems.
- Strong planning, prioritization, documentation, communication, and interpersonal skills.
- Analytical, meticulous, quality-focused approach with strong safety and timeline discipline.
- Ability to work independently and collaboratively while supporting continuous improvement.
Culture & Benefits
- Agile career development and a dynamic working culture in a global life sciences organization.
- Inclusive and ethical workplace focused on diversity, integrity, collaboration, accountability, excellence, and passion.
- Professional growth through cross-functional projects and global exposure.
- Comprehensive medical insurance with partially subsidized family coverage options.
- Company transport from designated MRT locations to and from the Tuas site.
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