4 дня назад
Senior QA Expert, Manufacturing 80-100%
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior QA Expert, Manufacturing 80-100% (Pharmaceutical Manufacturing): Providing QA oversight for shopfloor manufacturing and operational readiness in a GMP-regulated greenfield project with an accent on sterile manufacturing, aseptic process preparation, and controlled documentation. Focus on reviewing SOPs, coordinating deviations and CAPAs, supporting APS and media fill readiness, and maintaining inspection readiness.
Location: Stein, Aargau, Switzerland. Primarily site-based with remote work permitted for no more than 20% of the time. Relocation assistance is available for eligible candidates and their families.
Company
is a global life sciences company manufacturing medicines across more than 30 sites worldwide.
What you will do
- Provide QA oversight for shopfloor manufacturing activities in a growth project and ensure GMP compliance and operational readiness.
- Review and approve SOPs, work instructions, and other GMP documentation for start-up and sustainable manufacturing operations.
- Partner with Manufacturing teams on aseptic process readiness, including preparation, training support, APS, and future media fill activities.
- Lead and coordinate deviations, CAPAs, investigations, and related quality records through timely and effective resolution.
- Represent Quality in project discussions, audits, and inspections while supporting inspection readiness.
Requirements
- Proven pharmaceutical industry experience in a GMP-regulated environment, with expertise in sterile and/or drug product manufacturing.
- Experience with quality oversight, deviations, CAPAs, and investigations.
- Fluent German and fluent English are required.
- Willingness to spend significant time on the manufacturing shopfloor in full aseptic gowning is required.
- Bachelor’s, Master’s, or PhD degree in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology, or a related field.
- Pragmatic, solution-oriented mindset, strong stakeholder management skills, and adaptability in a dynamic greenfield project environment.
Nice to have
- Experience supporting regulatory and customer audits and inspections.
Culture & Benefits
- Agile career opportunities and a dynamic work culture.
- Inclusive and ethical workplace.
- Compensation programs recognizing high performance.
- Lifestyle, family, and leisure benefits.
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