Laboratorium Dr. G. Bichsel AG
Interlaken
2 months ago
CSV Manager (m/f) 100%
- Publication date:04 October 2025
- Workload:100%
- Place of work:Interlaken
Job summary
Join our team to enhance and develop our CSV system! Enjoy a supportive work environment with great benefits.
Tasks
- Build, maintain, and improve our CSV system per Annex 11 and GAMP.
- Validate and manage GMP-relevant systems, including ERP and IT infrastructure.
- Create and maintain validation documents and conduct risk analyses.
Skills
- Degree in science, pharmacy, or IT; GMP experience preferred.
- Strong communication and teamwork skills are essential.
- Fluent in German and English, both written and spoken.
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About the job
What you can achieve
- You are responsible for the setup, maintenance, and further development of our CSV system according to Annex 11 and GAMP
- You validate and support GMP-relevant systems such as production and monitoring systems, ERP, and IT infrastructure
- You create, review, and maintain validation documents (e.g., URS, FS, DS, IQ, OQ, PQ, IT inventory) and conduct risk analyses as well as changes to the computerized systems
- You are the contact person for CSV and Data Integrity and work closely with IT, production, technical, and quality departments
- You take over change management for the ERP as well as its account reviews
- You accompany audits and inspections in the CSV area and train colleagues on CSV and Data Integrity topics
What you bring with you
- You have a completed scientific, pharmaceutical, technical, or IT education; experience in a GMP-regulated environment is an advantage
- You ideally have knowledge in computer system validation and the relevant regulatory requirements (Annex 11/15, Data Integrity, GAMP) and guidelines (PIC/S, ICH Q9/Q10)
- Communication skills, team orientation, initiative, and a pragmatic, solution-oriented, structured, and analytical hands-on mentality characterize you
- Good German and English skills, both spoken and written, complete your profile
5 weeks vacation, with the possibility to purchase up to 10 additional vacation days or take unpaid leave
Pension fund with advantageous premium distribution - about 2/3 are covered by us
Various discounts in our pharmacies and with other top brands
Expand skills through funded and supported training and further education as well as internal development opportunities
Family-friendly with 16 weeks maternity leave (80% of salary) and 10 days paternity leave (100% of salary), as well as participation in child funds
Registered shares at preferential prices - not only engage professionally for Galenica but also invest
Mobile and flexible working in agreement with the team
