Description
We are looking for a
Qualification and Validation Specialist (m/f)
Reference: -en
Start: 03/16
Duration: 10 MM
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Define the qualification strategy for production/laboratory equipment, facilities, utilities and computerised Systems (CSV)
- Perform the qualification of new or upgraded production/laboratory equipment, facilities, utilities and CSV through the preparation of the necessary documentation and tests execution
- Contribute as SME to the URS preparation in support to the user for all defined steps
- Perform the impact assessments, design, prepare the commissioning and qualification documents and qualification reports
- Maintain the qualification status of existing systems production/laboratory equipment, facilities, and utilities according to a predefined frequency and in accordance with current internal SOPs
- Ensure compliance with the qualification standards of the equipment/utilities through continuous updating of procedures, according to international GMP standards and internal procedures
Your qualifications
- Superior understanding of CSV (profound relevant experience)
- Advanced knowledge in working with 21 CFR 820 and 21 CFR
- Experience in the pharma/medical or consumer product industry
- Fluency in English and German
Skills:
- Qualification/validation specialist
Keywords: Validierung Qualifizierung