Description
We are looking for a
GMP Qualification and Validation Services Expert (m/f)
Reference: -en
Start: asap
Duration: 5 MM+
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Define the validation strategy for computerized systems (CSV), equipment, facilities and utilities
- Perform the validation of new or upgraded production/laboratory computerized systems (CSV) and qualification of laboratory or production equipment/utilities/facilities through the preparation of the necessary documentation
- Participate as Subject Matter Expert to the URS preparation and provide support to the user for all defined steps
- Perform the impact assessments, design and prepare the commissioning and qualification/validation document and qualification/validation reports
- Collaborate in the upgrading documents and life cycle management of existing production/laboratory equipment, facilities and utilities according to a predefined frequency and in accordance with current SOPs
- Maintain the validation status of existing computerized systems according to a predefined frequency and in accordance with current internal SOPs
- Ensure compliance of the validation standards of the computerized systems through the continuous updating of procedures, according to international GMP standards and internal procedures
Your qualifications
- Profound experience in validation and qualification service, especially in the validation of CSV
- Proactive, open personality that recognizes Production, Quality and R&D departments as internal customers
- Team player with excellent communication skills
- Fluency in German (spoken and written) and good English skills (spoken and written)
- Experience in the implementation of new products and supporting the Engineering Qualification team
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Qualifizierung