Qualification Expert (m/f/d)
Freelance/temporary employment for a project Kaiseraugst Start date: asap Reference number: 815788/1
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Responsibilities
1. Responsible for planning and conducting qualification and validation activities
2. Creating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ)
3. Carrying out and documenting qualification processes for our Embedded Systems / process automation systems according to cGMP
4. Developing, implementing, and conducting test strategies, test plans, and test cases to verify system performance and compliance
5. Providing expertise in creating specifications (, URS)
6. Working with IT, process engineering / automation, quality assurance, and production departments to ensure smooth integration and qualification of the systems
7. Handling qualification impact assessments as part of change or deviation process management
8. Collaborating closely and communicating intensively with other departments
9. Providing assistance in the processing of deviations, changes and CAPAs
Profile
10. Technical degree in a relevant field
11. Further training and hands-on experience in the area of GMP
12. Solid experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
13. Hands on work experience in qualification
14. Experience with Siemens COMOS, eVAL (ValGenesis) and Veeva
15. Fluency in German spoken and written needed, English fluency written and reading comprehension
16. Independent and structured way of working with a self-reflecting behaviour and to continuously improve the processes
17. High degree of initiative, flexibility and quick comprehension skills
18. Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
Benefits
19. Unlimited project contract possible
20. Fascinating, innovative environment in an international atmosphere