Qualification Specialist
(m/f/d)
Freelance/temporary employment for a project Bulle Start date: asap Reference number: 841476/1
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Responsibilities
1. Define and implement the global qualification strategy, including risk assessments, plans, protocols, and reports
2. Ensure proper qualification and periodic requalification of GMP installations (equipment, software, utilities) in collaboration with external partners
3. Plan, coordinate, and maintain qualification activities, ensuring alignment with project timelines and external stakeholders
4. Create and update key documents such as the Qualification Master File (QMF) and Product Quality Review (PQR); drive continuous improvement of qualification processes and documentation
5. Lead and contribute to qualification-related and cross-functional technical or organizational projects
6. Act as Subject Matter Expert (SME) for qualification topics, including support for deviations, Change Controls, and audit/inspection readiness
7. Ensure compliance with cGMP standards and timely completion of required training
8. Use authorized documentation, perform analyses and double checks, and ensure reliable, accurate results
Profile
9. Good level of spoken and written French and English
10. Good level of proficiency with MSOffice tools
11. Basic knowledge of statistics
12. Excellent communication skills, for communicating with internal and external partners
13. Ability to structure ideas quickly and clearly
14. Excellent organization and problem-solving skills
15. Ability to define objectives and how to reach them
16. High capacity to anticipate issues, identify priorities and make decisions
17. High level of autonomy and good stress management skills
18. Solution-oriented and sensitive to customer needs
Benefits
19. A highly motivated team and an open way of communication
20. A very renowned company
21. We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position