5 дней назад
Senior QA Specialist, QA Analytics 80-100% (f/m/d)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior QA Specialist, QA Analytics 80-100% (f/m/d) (GMP analytics): Ensuring quality oversight for GMP-relevant QC and Analytical Development activities, with an accent on SOPs, analytical methods, validation, and pharmacopoeial compliance. Focus on reviewing investigations, deviations, changes, and CAPAs, supervising out-of-specification events, and supporting audits and health authority interactions.
Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families.
Company
is a global life sciences company manufacturing medicines across more than 30 sites on five continents.
What you will do
- Provide QA oversight to Quality Control and Analytical Development activities and ensure GMP requirements and SOPs are followed.
- Control and release GMP-relevant QC and Analytical Development documentation.
- Review and approve SOPs, analytical test methods, method transfer and validation protocols and reports, and gLIMS investigations.
- Supervise investigations of out-of-specification, out-of-expectation, and out-of-trend results.
- Own and revise SOPs, and ensure compliance in stability testing and reference standards.
- Review deviations, investigations, change requests, and CAPAs, while supporting inspections and audits.
Requirements
- Academic degree in Chemistry, Biotechnology, Life Sciences, or a related field.
- Significant pharmaceutical industry experience, preferably in QC or QA.
- Strong analytical expertise and experience with analytical method validation.
- Strong knowledge of cGMP regulations, including USP, European Pharmacopoeia, and Japanese Pharmacopoeia.
- Auditing experience and experience interacting with health authorities such as FDA and Swissmedic.
- Excellent written and verbal English communication skills.
Nice to have
- Knowledge of German.
Culture & Benefits
- Agile career development and a dynamic working culture.
- Inclusive and ethical workplace.
- Performance-based compensation programs.
- Benefits that depend on the role and location.
- Relocation assistance for eligible candidates and their families.
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