Quality Compliance Specialist 100% (limited) – OM Pharma – Meyrin, GE

In this position, you work for the Quality Management department and report to the Head of QA compliance and systems. You act as the quality representative for the Technical Projects and are responsible to deliver all related quality documentation on time. You also participate in the preparation and follow-up of the Health Authority inspections and act as an internal GMP auditor. We are offering a limited contract until the end of the year 2020. Your main tasks are the following:

  • Participate in the preparation of received audits (health authority inspections and partner audits)
  • Conduct internal audits according to annual program
  • Ensure CAPA plan follow-up
  • Write, review and/or approve project-related quality document such as quality policies, project quality plan, URS, VP, VMR, Risk analyses.
  • Ensure the preparation and follow-up of change requests.
  • Ensure the Quality Compliance support related to Design within the field of Technical Projects
  • Ensure the realization / centralization of all relevant quality risk analysis to be compiled within the site Quality Risk Plan and follow-up
  • Write, review or approve quality-related SOP
  • Manage deviation, change request and CAPA
  • Ensure follow-up of effectiveness check

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

  • University degree as Pharmacist, Biochemist, Chemist or similar
  • ideally 3 years’ experience in a quality assurance or quality compliance function within pharmaceutical industry
  • Previous experience in technical project
  • Strong knowledge of the compliance with guidelines related to GMP (EU & US)
  • Fluent in French and English both in oral and written conversation.

You are a pragmatic person who likes to identify and solve problems from the roots. Responsible and methodical, you enjoy taking initiatives and demonstrate a rigorous approach to document and file management, with high attention to details. You have excellent organizational skills and prioritize according to needs. You are an open communicator with good interpersonal skills, who is able to build good working relationships with colleagues.

The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Location: Switzerland – Meyrin/Geneva

Function: Technical Operations

Company: OM Pharma

Seniority Level: Specialist

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