5 дней назад
Specialist QC Stability and Raw Materials
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
Specialist QC Stability and Raw Materials (GMP/Pharmaceutical Quality Control): Coordinating stability studies and raw materials testing and release in a regulated biopharmaceutical laboratory with an accent on ICH compliance, pharmacopoeial specifications, and analytical data review. Focus on managing quality events, supporting product introductions and regulatory submissions, and coordinating QC activities across internal teams and external laboratories.
Location: Yverdon-les-Bains, Switzerland
Company
is a biopharmaceutical company operating a QC BioPlant and developing pharmaceutical products in a highly regulated environment.
What you will do
- Plan and coordinate raw materials laboratory activities and testing release.
- Design, initiate, execute, and report stability studies in accordance with ICH and regulatory requirements.
- Review internal and external analytical results and ensure completion within defined timelines.
- Coordinate with Quality Assurance, Manufacturing, Supply Chain, Warehouse, QC teams, and external laboratories.
- Support new product introductions, analytical transfer and validation interfaces, regulatory submissions, inspections, and audits.
- Lead deviations, investigations, CAPA, change controls, SOPs, work instructions, and other quality documentation.
Requirements
- Bachelor’s degree with at least 5 years of experience, or CFC/BTS in physicochemistry or biotechnology with at least 10 years of laboratory experience.
- Strong experience in a GMP environment within a pharmaceutical or biotechnology company.
- Deep knowledge of analytical testing and pharmacopoeias, including USP, European Pharmacopoeia, and JP.
- Fluent French and advanced English at C1 level required.
- Ability to work in a highly regulated and fast-changing environment with a rigorous, organized, proactive, and pragmatic approach.
Culture & Benefits
- Cross-functional work across Quality, Manufacturing, Supply Chain, Regulatory Affairs, and laboratory teams.
- Strong focus on quality, integrity, ethics, legal compliance, and company guidelines.
- Delegation and operational support from the QC Lab Operations Manager.
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