QA Manager, QA Analytics 80-100% (f/m/d)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
QA Manager, QA Analytics (Pharmaceutical Quality): Ensuring QC processes comply with GxP, data integrity, regulatory, and internal quality standards with an accent on analytical quality systems, document approval, and compliance oversight. Focus on leading deviation investigations, CAPA and effectiveness checks, supporting audits and inspections, and guiding cross-functional stakeholders across the site.
Location: Visp, Switzerland; relocation assistance is available for eligible candidates and their families
Company
is a global life sciences and pharmaceutical manufacturing company operating across more than 30 sites worldwide.
What you will do
- Represent QA Analytics in cross-functional teams and act as the interface between QC and QA Operations.
- Ensure QC activities meet GxP requirements, applicable procedures, and internal and external quality standards.
- Review and approve analytical method transfer and validation documents, SOPs, and QC-related records.
- Lead decision-making and ensure appropriate investigation and documentation of QC deviations and OOx investigations.
- Drive CAPA and effectiveness check activities to timely completion and closure.
- Support projects, regulatory inspections, customer audits, and provide subject matter expertise to internal and external stakeholders.
Requirements
- Academic degree in Chemistry, Biochemistry, Biotechnology, Life Sciences, or a related field.
- Profound experience in the pharmaceutical industry within QC or QA.
- Analytical expertise, including method validation, change management, deviation management, and OOx investigations.
- Strong knowledge of cGMP regulations, including USP, European Pharmacopoeia, and Japanese Pharmacopoeia.
- Auditing experience and experience interacting with health authorities, including FDA and Swissmedic.
- Excellent written and verbal English communication skills required.
Nice to have
- German language skills.
- Experience working in cross-functional teams.
Culture & Benefits
- Agile career opportunities and a dynamic working culture.
- Inclusive and ethical workplace.
- Performance-oriented compensation programs.
- Benefits vary according to role and location.
- Relocation assistance for eligible candidates and their families.
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