Qualification Expert (m/f/d)
- Initiate, support and supervise qualifications of analytical equipment, including Computer System Validation (CSV), in close collaboration with the analytical laboratories
- Act as System Owner for analytical laboratory instruments.
- Write and review documents related to your field of work (e.g. SOPs) to ensure compliance to global guidelines.
- Contribute to evaluation of new scientific technologies/equipment
- Ensure compliance to cGMP and HSE according to applicable regulatory requirements and guidelines. Support Health Authority inspections and Audits.
- Actively participate in global teams, projects, networks and/or platforms
- Apprenticeship, BSc or MSc in Chemistry, Biology or similar field
- Several years of work experience in qualifying laboratory instruments and Computer System Validation in a GMP environment is a must
- Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations
- Fluent in English (oral and written). German is desirable
Novartis Pharma AG
4056 Basel [CH]