1 день назад
Analyst, QC (Biochemistry)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst, QC (Biochemistry) (Biopharmaceutical Quality Control): Performing biochemical testing and supporting the release of final, in-process, and stability samples in a GMP-regulated laboratory with an accent on analytical methods, method transfers, validations, and data integrity. Focus on investigating OOS events and deviations, troubleshooting laboratory methods and equipment, and maintaining compliant quality documentation.
Location: Tuas, Singapore
Company
manufactures biopharmaceutical products and therapies through globally connected operations across more than 30 sites.
What you will do
- Perform and prioritize testing of final product, in-process, and stability samples using approved methods, SOPs, and cGMP requirements.
- Execute biochemical and analytical techniques including ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency assays, and Biacore.
- Support method transfers, method validations, equipment qualification, laboratory troubleshooting, and operational readiness activities.
- Document, review, and maintain laboratory data and records according to GMP and data integrity principles.
- Investigate OOS events, deviations, and analytical issues, including root cause analysis and technical report generation.
- Maintain quality documentation and contribute to laboratory operations, continuous improvement, equipment maintenance, reagent preparation, and technical training.
Requirements
- Degree or higher qualification in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related discipline.
- At least 5 years of quality control or laboratory experience in the biopharmaceutical, biotechnology, or pharmaceutical industry.
- Hands-on experience with biochemical and analytical techniques such as ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency assays, and Biacore.
- Experience with method transfers, method validations, equipment qualification, and laboratory investigations.
- Understanding of cGMP requirements, quality management systems, data integrity principles, and FDA, EMA, and ICH guidelines.
- Strong analytical, troubleshooting, problem-solving, communication, and quality decision-making skills, with the ability to work independently and prioritize effectively.
Culture & Benefits
- Agile career environment with ongoing learning and professional development opportunities.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Collaboration with global cross-functional teams.
- Compensation programs that recognize high performance.
- Commitment to diversity, safety, quality, and operational excellence.
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