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Our client, a biotech company located in Zwijnaarde, is a global biotechnology firm bringing innovative CAR-T cell therapy to Ghent. The company makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases. They are currently experiencing significant growth and are seeking motivated and dedicated team members.
Document Control Specialist
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:
- Oversee, maintain, and continuously optimize document control systems and processes for the facility.
- Review newly created and revised procedures to ensure they align with both local and global standards.
- Offer guidance to users regarding document workflows and electronic document management systems.
- Manage the scheduled review process for procedures.
- Issue batch-related documentation in support of GMP manufacturing activities.
- Reconcile GMP documents according to lifecycle requirements.
- Prepare and distribute GMP logbooks.
- Supervise the storage, retention, and archiving of GMP records and batch documentation.
- Ensure all tasks are performed in compliance with safety protocols, quality systems, and current GMP regulations.
- Review and approve SOPs and other controlled documents.
- Lead continuous improvement initiatives within the document management process.
- Utilize advanced computer skills to enhance efficiency and support technical/scientific capabilities.
Profiel
We are looking for you in case you have:
- Nice experience within administration, where you are used to handling complex tasks.
- Excellent written and verbal communication skills in Engllish.
- Analytical problem-solving, and conflict resolution abilities.
- Highly organized, motivated, and capable of multitasking with attention to detail.
- Ability to adapt to shifting priorities and meet critical deadlines in a dynamic and fast-paced environment.
- Effective interpersonal skills for communication across organizational levels.
- Ability to work independently with strong accountability.
- Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
- Familiarity with Document Management Systems (TruVault/Veeva) is preferred.
Aanbod
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Van € 2.600 tot € 2.800 per maand
What We Offer:
- Competitive salary package with meal vouchers of €7/day. After 6 successful months there is an option for a permanent contract!
- A rewarding position with excellent work-life balance; work 4 days per week (10 hours/day), and 4 days off.
- A supportive and innovative work environment that fosters learning and personal growth.
- Opportunities to collaborate with colleagues from diverse backgrounds.