Description
We are looking for a
Quality Assurance Validation Specialist (m/f)
Reference: -en
Start: 02/15
Duration: 6 MM+
Place: in German-speaking Switzerland
Branch: Erbringung von sonstigen Dienstleistungen a. n. g.
Your tasks:
- (Re)qualification of computerised systems
- Generation of IT archive structures
- Approval of IT qualification/validation documentation
- Support for IT, Facility, Engineering & Operations in QA relevant documentation aspects related to computerised systems
- Execution of periodical reviews on computerised systems
- Support & approval of change control within computerised systems
- Support in issuing new SOPs related to qualification/validation of computerised systems
- Gap analysis and definition of action items within computerised systems
- Update of templates to simplify documentation/processes
- QA leadership of qualification/validation activities in cooperation with IT
Your qualifications
- IT/IT-related education or engineering qualification with strong IT background
- Experience in regulative compliance/quality assurance
- Experience in validation of computerised systems
- Technical understanding of computerised systems/ machines & processes
- Excellent IT knowledge regarding computerized systems
- Ability to drive continuous process and quality improvement in a regulated environment (GMP)
- High sense of responsibility
- Excellent communication skills
- Interest in adequate documentation practices
Skills:
- Qualification/validation specialist
- Quality manager
Keywords: Qualitätsmanager