Qualification Validation Manager (m/f/d) 100% - TEMPORARY FOR 12 MONTHS Company information
Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell&Gene Therapy and Cosmetic industries. With headquarters near Basel, Switzerland, over 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.
Be part of your challenge: take a big jump and do the change of your life! Job Description
1. Executes establishment and maintenance of Equipment Qualification System for the Operations
2. Ensures proper qualification of equipment/instruments/computerized-systems and method validation/transfer/qualification/verification by guaranteeing adherence to the corresponding regulation requirements
3. Acts as first contact for equipment qualification & maintenance within QA as well as equipment qualification document life cycle management and compliance issues for equipment qualification in shared systems (e.g. LIMS / CDS)
4. Supervises and executes compliance activities including but not limited to releasing method validation/transfer/qualification/verification documents and to assigning GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, CAPAs, audit observations, vendor change notification
5. Takes care of proper qualification of GMP staff by supervising adherence to GMP trainings as well as of equipment supplier /services by supervising adherence to quality agreements
6. Advises on preparation of service agreements, URS, DQ and qualification documents
7. Keeps track of GMP status of equipment/instruments/ computerized systems
8. Support deviations management and continuous process improvement in the area of responsibility
Requirements
9. > 4 years working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance
10. Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems
11. Solid know-how in EU and US GMP regulations relevant for computerized systems validation
12. Advanced knowledge in Data Integrity rules and requirements
13. Excellent communication and decision-making skills
14. Ability to provide solutions for complex challenges and work independently in a team environment
15. Solution oriented, precise, and organized
16. Good inter-personal skills
17. Energized and open-minded
18. Willingness to learn and carry out new and complex tasks
19. Proactive attitude
20. Excellent in German and English, French is a plus
Our employees are very close to our hearts. At Solvias you get
21. a well-structured onboarding program
22. intensive training in the beginning
23. the possibility for further development
Furthermore, there are a multiple range of benefits like
24. flexible working time models
25. 40 hours week
26. at least 28.5 vacation days per year (depending on your age)
27. commuter contribution for using public transport
28. staff restaurant