23 часа назад
QA Expert Analytics 9 months fix-term contract 80-100% (f/m/d)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Expert Analytics (GMP): Supporting quality assurance for clinical and commercial analytical testing laboratories in a GMP-regulated drug product environment with an accent on method validation, release testing, stability studies, and electronic quality systems. Focus on reviewing deviations, OOS investigations, CAPAs, and change controls while supporting batch release, audits, and health authority inspections.
Location: Basel Stücki, Switzerland
Company
is a life sciences company manufacturing medicines across more than 30 sites on five continents.
What you will do
- Provide QA support to clinical and commercial QC functions for GMP compliance activities in physicochemical and bioassay testing laboratories.
- Ensure adherence to GMP quality manuals, quality standards, and HSE regulations across drug product testing sites.
- Review and approve analytical method validation, specifications, release testing, stability studies, and related GMP documentation.
- Perform approvals in LIMS, iLab, DMS, Trackwise or equivalent GMP-relevant systems.
- Review deviations, OOS investigations, CAPAs, and change controls related to products, processes, and analytical activities.
- Support analytical and technical release of drug product batches, customer audits, health authority inspections, and continuous improvement initiatives.
Requirements
- University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific discipline.
- Several years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Proven QA experience supporting QC laboratories and analytical testing activities.
- Strong knowledge of GMP regulations, quality systems, analytical laboratory operations, and electronic quality or laboratory systems.
- Experience managing and reviewing deviations, OOS investigations, CAPAs, and change controls.
- Excellent written and spoken English required. Good communication and stakeholder management skills in a matrix environment.
Culture & Benefits
- Agile career opportunities and a dynamic work culture.
- Inclusive and ethical workplace.
- Compensation programs recognizing high performance.
- Collaborative, accountable, excellence-focused, passionate, and integrity-driven working environment.
- Commitment to diversity and inclusion.
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