Realdev
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QA Computer System Validation

Bruxelles, Belgium

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QA Computer System Validation


RealDev is a dynamic Technology and Management Consulting Group located in Belgium. Our teams have taken on multiple consulting projects, assisting in the development of leading competitors in various sectors.We are committed to finding efficient solutions for sustainable growth and profit.Our positive, motivated, and challenging team environment is seeking talented expert.

Job description

Within one of our challenging projects, we are looking to expand our team of experts in QA CSV.

Project responsabilities:

·         Manage QA activities related to the following Quality systems Change Control, Deviations, CAPA, periodic review, …

·         Ensure the proper execution of the qualification and validation activities with respect of the our client validation methodology

·         Writing, reviewing and approving of validation plans and validation summary reports

·         Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …

·         Reviewing and approving of CSV specific SOP’s and Templates

·         Coach the User, Technical Services and other QA departments in the internal methodology applied to automated and computerized systems.

·         Support team and management during internal and external audits

Qualifications

·         Degree in automation, engineering, IT, sciences or equivalent by experience

·         Minimum 2 to 5 years’ experience in a computer systems validation role

·         Good knowledge of French and English

·         CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)

·         Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)

·         Technical knowledge of automated and computerized systems

  • English : Fluent

  • French : Fluent

  • Contract Type : Permanent

  • Duration of the first project : 12 months (Extensible)

  • Location : Brussels

Conditions

At RealDev, we are seeking to expand our team of experts by investing in individuals who are capable of taking on challenging projects. We’re offering exciting positions in a dynamic and professional company. Our positions provide great opportunities to develop your career while working in driven environments and industries with sector leaders.