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Quality Assurance Manager
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.
Quality Assurance Manager
The quality assurance (QA) Manager is a key position to the national and international development of Bio.be activities. The QA Manager will report to the Head of Bio.be and collaborate with QA Department. This position will require routine coordination with multidisciplinary operational teams dedicated to the services to our Pharma/Biotech partners. Experience in GxP environment is highly desired.
- 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
- 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)
- Result Oriented
- Methodical, organised and persistent
- Creative and dynamic
- Assertiveness and empathy; Good interpersonal and communication skills
We offer :
- A long-term contract, full time (40h with time recovery scheme)
- A salary according to your experience with extra benefits
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