CSV Consultant

Experis recognises you are more than just a CV. As part of the ManpowerGroup we have access to a huge network of opportunities and we'll connect you to the roles that will accelerate your career.

For our international client based in Basel Switzerland, Experis is currently looking for a Qualification and Validation Consultant (CSV) to start on a new project. The role is for an experienced professional who can work under GMP CFR part11 guidelines and will be a great opportunity to work with some of the most interesting systems in a globally renowned company. The role is for a 6-12 month contract (initially 6, high likelyhood of extension)

Responsibilities

- (Re)qualification of computerized systems
- Generation of IT archive structure
- Approval of IT qualification/validation documentation
- Support of IT, Facility, Engineering & Operations in QA relevant documentation aspects related to computerized systems
- Execution of periodical reviews on computerized systems
- Support & approval of change control on computerized systems
- Support in issuing new SOPs related to qualification/validation of computerized systems
- Gap analysis and definition of action items on computerized systems
- Update of templates to simplify documentation/processes
- QA leadership of qualification/validation activities in cooperation with IT department
- Good knowledge and application of GMP relevant guidelines (CFR part11 & Annex 11)
- Validation of excel spread sheets

Requirements

- Technical understanding of computerized systems/machines & processes
- High sense of responsibility
- Excellent IT knowledge on computerized systems
- Ability to drive continuous process and quality improvement in a regulate environment (GMP)
- IT/IT related education or qualification engineer with strong IT background
- Experience in regulative compliance/quality assurance
- Validation of computerized systems

LOCATION: Basel

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Sebastian Pal