Functieomschrijving
We are seeking a dedicated Document Control Specialist to oversee and enhance the document management processes within our cell therapy manufacturing facility, catering to both clinical and commercial needs in a sterile, GMP-compliant environment. This role is pivotal in ensuring adherence to document management standards, proper storage, retention, issuance, and reconciliation of documentation.
Tasks:
1. Oversee and refine the document control systems and procedures for the facility.
2. Act as a reviewer for new and updated procedures and documents, ensuring alignment with global and site-specific standards.
3. Assist users with document management workflows and electronic systems.
4. Manage the regular review cycle for procedures.
5. Issue batch-related documentation to support GMP manufacturing operations.
6. Ensure GMP documentation is reconciled according to lifecycle requirements.
7. Develop and distribute GMP logbooks.
8. Handle the storage and archival of GMP documents and batch records.
9. Execute tasks in compliance with safety policies, quality systems, and cGMP standards.
10. Review and validate SOPs and other critical documentation.
11. Promote continuous improvement initiatives.
12. Utilize advanced computer skills to boost departmental productivity and expand technical and scientific expertise.
Profiel
Education:
13. Bachelor’s degree, secondary degree, or equivalent experience.
Skills and Competencies:
14. Proficient understanding of GxP Quality Systems and relevant regulations (., EU GDP/GMP, MHRA).
15. Operational knowledge of electronic quality systems.
16. Familiarity with Document Management Systems (TruVault/Veeva) is preferred.
17. Excellent written and verbal communication skills, analytical problem-solving, and conflict resolution abilities.
18. Highly organized, motivated, and capable of multitasking with attention to detail.
19. Ability to adapt to shifting priorities and meet critical deadlines in a dynamic and fast-paced environment.
20. Effective interpersonal skills for communication across organizational levels.
21. Ability to work independently with strong accountability.
22. Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
Aanbod
What We Offer:
23. A rewarding position with excellent work-life balance; work 4 days per week (10 hours/day).
24. A supportive and innovative work environment that fosters learning and personal growth.
25. Opportunities to collaborate with colleagues from diverse backgrounds.
26. Initial engagement through interim contracts, transitioning to a permanent contract after six months.
27. Competitive salary package with numerous benefits, including extra statutory vacations, meal vouchers of €7/day, group and hospitalization insurance upon permanent contract, double vacation pay, and performance bonuses.