Description
We are looking for a
GMP Qualification and Validation Specialist (m/f)
Reference: -en
Start: 03/16
Duration: 4 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 computerized systems (CSV)
- Perform the qualification of new or upgraded production/laboratory equipment, facilities, utilities and CSV through the preparation of the necessary documentation and test execution
- Contribute as SME to the URS preparation in support to the user for all defined steps
- Perform 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 of the qualification standards of the equipment/utilities through the continuous updating of procedures, according to international GMP standards and internal procedures
Your qualifications
- Advanced knowledge of and experience in the GxP area
- Profound relevant experience in CSV
- Advanced knowledge of 21 CFR 820
- Fluency in English and German
Skills:
- Qualification/validation specialist
Keywords: Validierung Qualifizierung