QA CSV Manager (f/m/d) 80-100%
Key information
- Publication date:10 March 2025
- Workload:80 – 100%
- Contract type:Unlimited employment
- Language:German (Fluent), English (Fluent)
- Place of work:Bubendorf
Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot. Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz. In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.
To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our new Global Quality Unit, we are looking for a dedicated QA CSV Manager (f/m/d) 80-100% in a newly created position.
Your tasks
- Ensure computerized systems are appropriately validated according to Bachem internal standards
- Review and approve CSV documents (e.g. validation plan/report, URS, FS, risk assessments, test protocols and test reports)
- Guide and support teams implementing new projects to define and implement the appropriate way of CSV
- Join future IT-related projects as QA representative
- Oversee and support the life-cycle management of validated software systems incl. change management, periodic review, and system retirement
- Provide training on CSV policies, SOPs, to internal stakeholders e.g. project team members, system owners
- Participate in customer audits and authority inspections as CSV subject matter expert
- Support the re-/evaluation of suppliers for software solutions
- Maintain a close liaison with internal stakeholders e.g. Global IT, OT, MSAT, Quality Control
Your profile
- Bachelor's degree or equivalent qualification in information technologies, life sciences (chemistry, engineering) or similar
- At least 3 years practical experience in computerized system validation in cGMP regulated environments in Quality Management departments, IT departments, or equivalent Consultant positions
- Knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards
- Detail oriented with the ability to troubleshoot and resolve problems.
- Hands-on when required
- Ability to effectively work in a fast-paced, deadline driven work environment
- Ability to work independently and manage one's time
- Ability to communicate in a proactive and solution-focused manner
- Experience in working in cross-functional teams
- Fluency in English (spoken and written), German also preferred
Our offer
- A dynamic and rapidly growing working environment with internal development opportunities
- Flexible working hours with the possibility of home office
- Employee development through numerous internal and external training opportunities
- As standard, Bachem AG pays 60% of the pension fund contributions
- Access to the Swibeco benefits platform with many discounts at external partners
- Fresh, healthy, and varied food in our staff restaurant
- A wide range of free sports activities on the Bachem Campus
Would you like to drive innovation together with us?
Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf!
