QA Compliance Manager (fixed term contract) - Geneva

Vifor Pharma — Geneve
23.11.2019 | Employee | 100%

QA Compliance Manager (fixed term contract) - Geneva

In this position, you work for the Quality Management department and report to the Head of QA compliance and systems. You are responsible for the GxP compliance of IT system of Geneva’s site and are accountable for Data Integrity and Computerized System validation in compliance with GxP. You also participate to the preparation and follow-up of the Health Authority inspections and act as an internal GMP auditor. We are offering a 2 years’ contract. Your main tasks are the following:

  • Ensure that locally implemented SOPs are defined with respect to regulatory requirements and correctly applied
  • Review and approve all SOP & documentation related to the definition of IT systems quality requirements
  • Perform, review or approve periodical review of IT systems
  • Manage all deviations, CAPA and change control related to IT systems (ERP, LIMS, etc)
  • Act as project member for any IT GxP related projects
    Manage the qualification process for IT system suppliers
  • Act as front/back office during health authority inspections and ensure CAPA plan follow-up
  • Act as a back-up key user for LMS / EDMS

For this challenging position, we are looking for a rigourous and solution-oriented person bringing the following profile:

  • University Degree as Pharmacist, Biochemist, Chemist or similar
  • At least 3 years’ experience in a quality assurance or quality compliance function within pharmaceutical industry
  • Strong knowledge of the GMP and pharmaceutical guidelines
  • Experience with Data Integrity and IT systems validation
  • Fluent in French and English both in oral and written conversation.

You feel comfortable in a role where you work with cross functional stakeholders and support them in all quality and compliance related aspects IT systems. You would describe yourself as an highly-motivated person with very good analytical skills, who likes to convince others and help them to take the decisions.

23.11.2019
Employee, 100%

Contact

Vifor Pharma

Marilda Martins

Phone: '+41 58 851 67 69

Fax: +41 58 851 80 03

Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical

Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical
Salary

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