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Quality Assurance Manager (M/F)

February 3rd 2020

Bio.be is an entity of the Institute of Pathology and Genetics (IPG), a Belgian human diagnostic company offering bio-analytical testing in Molecular Biology, Cytogenetics and Immuno-histochemistry for the Pharma and Biotech Industry.

Mission Description

Main tasks/Responsibilities:

  • Development (writing), implementation and continuous improvement of quality systems (standard operating procedures, forms and working practice documents) in compliance with GxP and other applicable regulations and guidelines.
  • Organize QA meetings with operational teams (Samples Reception Department, Project Management Office and laboratories) in order to provide recommendations in alignment with regulatory requirements
  • Maintains updated and relevant knowledge of the GxP landscape, regulations, and guidelines
  • Setup and monitoring of non-conformities and CAPA in collaboration with the appropriate departments
  • Review all change controls  in compliance to the change control management system
  • Undertakes initiatives for continuous improvement of the process
  • Performance of internal audits
  • Preparation and follow-up of client audits and inspections by the competent authorities
  • Annual appraisal of the Bio.be quality system with the Head of Bio.be and the CEO
  • Follow-up of quality metrics for Bio.be
  • QA training

Candidate profile

Requirements/Qualification:
• Hard Skills/Experience
- Master degree in a scientific discipline
- Experience of at least 5 years in a similar function in a medical laboratory or in a pharmaceutical/biotech company and in a GxP environment
- Fluent in French and English (oral and written)
- Extensive knowledge of GxP regulations and industry practices
- Good command of Microsoft Office (Excel, Word, Power Point)


• Soft Skills
- Result Oriented
- Methodical, organised and persistent
- Creative and dynamic
- Assertiveness and empathy; Good interpersonal and communication skills
- Proactive

 

Offer

We offer :

 

  • A long-term contract, full time (40h with time recovery scheme)
  • A salary according to your experience with extra benefits

 

 

Contact Details

To apply, send your résumé ans cover letter to jobs@ipg.be or you can apply directly on the website