CSV Manager (m/f) 100%
Laboratorium Dr. G. Bichsel AG
Interlaken
Key information
- Publication date:04 October 2025
- Workload:100%
- Place of work:Interlaken
Job summary
Join our team at Galenica to innovate in CSV and Data Integrity. Enjoy a supportive work culture with great benefits!
Tasks
- Develop and maintain our CSV system per Annex 11 and GAMP standards.
- Validate and support GMP-relevant systems like ERP and production systems.
- Create and manage validation documents, ensuring compliance and quality.
Skills
- Degree in science, pharmacy, tech, or IT; GMP experience preferred.
- Strong communication and teamwork skills for effective collaboration.
- Proficient in German and English for clear documentation and training.
Is this helpful?
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 computer-based 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 area of CSV 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
