17 часов назад
QC Specialist (Environmental Monitoring)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Specialist (Environmental Monitoring): Establishing and operating a state-of-the-art QC laboratory for a new Singapore Modulus Facility with an accent on GMP-compliant environmental monitoring, equipment qualification, and microbiology support. Focus on developing sampling plans, investigating deviations and contamination events, trending environmental data, and providing technical leadership across manufacturing, engineering, validation, and quality teams.
Location: City of Singapore
Company
develops healthcare solutions and operates global manufacturing facilities for vaccines and biological platforms, including mRNA products.
What you will do
- Perform routine environmental monitoring sampling, data review, trending, and documentation in accordance with GMP requirements.
- Develop and coordinate environmental monitoring plans and schedules for routine, ad hoc, aseptic qualification, equipment qualification, BSC, and isolator activities.
- Lead IQ/OQ/PQ qualification and requalification of environmental monitoring equipment, including calibration of air samplers and particle counters.
- Lead investigations into environmental monitoring excursions, deviations, contamination events, CAPAs, and change controls.
- Own environmental monitoring SOPs, work instructions, and GMP documentation while managing microbial isolate conservation and supporting validation activities.
- Serve as the environmental monitoring subject matter expert and trainer, providing troubleshooting support and collaborating with Manufacturing, Engineering, Validation, QA, and other stakeholders.
Requirements
- Degree in Microbiology, Life Sciences, or a related scientific discipline.
- Approximately 5–8 years of experience in a pharmaceutical or biopharmaceutical microbiology laboratory.
- Strong knowledge of Environmental Monitoring and cGMP regulations, including EU and US requirements.
- Experience with risk-based approaches and operational excellence.
- Good communication skills and the ability to lead cross-functional collaboration in a fast-paced environment.
- Proficiency in English required.
Culture & Benefits
- Opportunity to contribute to the start-up of a new, fully digitalized manufacturing facility.
- Work on flexible and environmentally responsible production units supporting multiple vaccine and biological platforms.
- Collaborate with diverse teams united by a focus on improving patient outcomes.
- Equal-opportunity workplace committed to diversity, equity, and inclusion.
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