CSV Consultant
Brabant Wallon – Contracting
Our partner is looking for a CSV Consultant to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
- Writing, reviewing and approving of validation plans and validation summary reports
- Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
- Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
- Writing and reviewing of Periodic Review Reports (PR)
- Reviewing and approving of CSV specific documentation (inventory, …)
- Reviewing of CVS specific SOP’S and Templates
- Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerised systems.
- Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerised systems.
- Support team and management during internal and external audits
Your profile?
- University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- 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, …
- Fluent in French and able to communicate in English
Our offer?
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.
