Computer System Validation
Brabant Wallon – contracting
Our partner is looking for a Computer System Validation to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
- Writing, reviewing and approving of validation plans and validation summary reports
- Reviewing and approving of Technical Change Description
- Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
- Reviewing of CVS specific SOP’S and Templates
- Ensure the proper execution of the qualification and validation activities with respect of the company validation methodology
Who are you ?
- University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- You speak French and English
- Certification in computer system validation or equivalent is a plus.
- Experience in a computer systems validation role
- 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, …)
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
