Functietitel: Senior QA Consultant

Functieomschrijving:

For one of our partners in the region of Breda, we are currently looking for an experienced QA Consultant. You’ll advice new projects in setting up Design Control documentation and design history file structure. You’ll support projects with compliance to medical device and combination product quality standards and regulatory guidances and directives.

• Provide expertise on documentation to ensure compliance to Health Authority regulations
• Review and give guidance on key design control documents such as the essential requirement list and the clinical evaluation report
• Support and participate in key project meetings (e.g. Design reviews)
• Lead and coordinate the establishment of QA agreement with third parties
• Coordinate training requirements for the team regarding SOPs, GMP, ...
• Monitor the release of new applicable standards and regulations
• Provide guidance for the internal quality tracking system (EDMQ, CCMS Trackwise)
• Lead and support the development of new procedures and SOPs
• Monitor internal quality compliance

Company:

Pauwels Consulting is a fast-growing technical consultancy firm with a large portfolio of international corporate clients in Engineering, Pharma and IT. We deliver consultancy and turnkey projects to leading companies in Belgium and beyond.

At Pauwels Consulting we value your talent and ambitions. That is why we invest heavily in the continuous education, personal coaching and individual development of all our consultants. At Pauwels Consulting, you will find a challenging and inspiring work environment every single day.

Are you interested in working for top companies in your industry and do you like to improve your skills and expertise every day? Then we should definitely meet! We look forward to hearing from you via phone (+32 9 324 70 80) or e-mail (jobs (at) pauwelsconsulting.com).

• A position with responsability within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

• At least 3 years of experience in a pharmaceutical or medical device industry within the QA Department
• Vast experience in writing and reviewing design control documents and compilation of design history files
• Relevant experience preferred in :
  • Computerized System Validation (CSV)
  • Software Medical Device Quality
  • NC, CAPA, Change Control
• Excellent knowledge in GMP and GLP
• Good understanding of cross-functional drug and device development processes
• Excellent communication and presentation skills as well as scientific and technical writing skills
• Fluency in English is required

Werkgever Naam: Pauwels Consulting

Werkgever adres: Pauwels Consulting, , 9000 GENT, BELGIE

Vorm van contact: Isabelle Ballegeer

Job korte beschrijving:
Leidinggevende functies op het gebied van informatie- en communicatietechnologie

Land: Nederland

Regio: NEDERLAND

Contractduur: Vast

Contract type: Voltijds

Ervaring: Tussen 2 en 5 jaar

Bron van jobaanbieding:
VDAB, Openbare diensten voor arbeidsvoorziening, België

Hoe toe te passen: Overig - zie vrije tekst