CSV Consultant
CSV Consultant - Basel
Alex Tosney is recruiting for a CSV Consultant to join a company in the drug discovery industry at their site based in Basel on a 6-contract basis.
The main purpose of the role will be to:
- Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with the company's requirements and, where appropriate, in accordance with regulatory requirements.
- Deliver support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11.
- Offer support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements.
Further responsibilities will include:
- Determining regulations that are applicable to a computerized system and need for validation.
- Applying advanced knowledge and experience to address complex issues.
- Acting as a primary contact person between the computerized system project team and Pharmaceutical Development Department.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Good knowledge and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11.
- Solid experience in Computerized Systems Validation (CSV).
- University degree with suitable qualification in the pharmaceutical industry area.
This is an excellent opportunity to join a growing company in the pharmaceutical industry.
For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 41 7825 08 443 or email atosney@ckqls.ch. Please could you send any correspondence in English. Please quote reference 47052 in all correspondence.
