Description
We are looking for a
Computer system validation expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel-Country
Branch: Erbringung von sonstigen Dienstleistungen a. n. g.
Your tasks:
- (Re)qualification of computerized systems
- Generation of IT archive structures
- Approval of IT qualification/validation documentation
- Support for IT, Facility, Engineering and Operations in QA relevant documentation aspects related to computerized systems
- Execution of periodical reviews on computerized systems
- Support and approval of change control on computerized systems
- QA leadership of qualification/validation activities in cooperation with IT department
Your qualifications
- IT/IT-related education or qualification engineer with strong IT background
- Experience in regulative compliance/quality assurance
- Experience in validation of computerized systems
- Good knowledge and application of GMP relevant guidelines (CFR part11 and Annex 11)
- Very good English and German knowledge
Skills:
- Administrator