Functieomschrijving
We are seeking a dedicated Document Control Specialist to enhance and streamline document management practices at our cell therapy manufacturing facility. This role supports both clinical and commercial operations within a sterile, GMP-compliant environment. The position is vital in ensuring compliance through the proper handling, storage, issuance, retention, and reconciliation of critical documentation.
Key Responsibilities:
1. Oversee, maintain, and continuously optimize document control systems and processes for the facility.
2. Review newly created and revised procedures to ensure they align with both local and global standards.
3. Offer guidance to users regarding document workflows and electronic document management systems.
4. Manage the scheduled review process for procedures.
5. Issue batch-related documentation in support of GMP manufacturing activities.
6. Reconcile GMP documents according to lifecycle requirements.
7. Prepare and distribute GMP logbooks.
8. Supervise the storage, retention, and archiving of GMP records and batch documentation.
9. Ensure all tasks are performed in compliance with safety protocols, quality systems, and current GMP regulations.
10. Review and approve SOPs and other controlled documents.
11. Lead continuous improvement initiatives within the document management process.
12. Utilize advanced computer skills to enhance efficiency and support technical/scientific capabilities.
Profiel
We are looking for you in case you have:
13. Nice experience within administration, where you are used to handling complex tasks.
14. Excellent written and verbal communication skills in Engllish.
15. Analytical problem-solving, and conflict resolution abilities.
16. Highly organized, motivated, and capable of multitasking with attention to detail.
17. Ability to adapt to shifting priorities and meet critical deadlines in a dynamic and fast-paced environment.
18. Effective interpersonal skills for communication across organizational levels.
19. Ability to work independently with strong accountability.
20. Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
21. Familiarity with Document Management Systems (TruVault/Veeva) is preferred.
Aanbod
What We Offer:
22. Competitive salary package with meal vouchers of €7/day. After 6 successful months there is an option for a permanent contract!
23. A rewarding position with excellent work-life balance; work 4 days per week (10 hours/day), and 4 days off.
24. A supportive and innovative work environment that fosters learning and personal growth.
25. Opportunities to collaborate with colleagues from diverse backgrounds.