Description
We are looking for a committed Document Control Specialist to support and optimize document management practices within our cell therapy manufacturing facility. This role spans both clinical and commercial operations in a sterile, GMP-compliant setting. The position plays a key role in maintaining compliance by ensuring proper handling, storage, issuance, retention, and reconciliation of critical documentation.
Key Responsibilities:
* Manage, maintain, and continuously improve document control systems and processes for the site.
* Review newly created and revised procedures to ensure alignment with site and global standards.
* Provide guidance to users on document workflows and electronic document management systems.
* Oversee the scheduled review cycle of procedures.
* Issue batch-related documentation in support of GMP manufacturing activities.
* Reconcile GMP documentation in accordance with lifecycle requirements.
* Prepare and distribute GMP logbooks.
* Oversee the storage, retention, and archival of GMP records and batch documentation.
* Perform all tasks in compliance with safety policies, quality systems, and current GMP regulations.
* Review and approve SOPs and other controlled documents.
* Champion continuous improvement initiatives within document management.
* Leverage strong computer proficiency to increase efficiency and strengthen technical/scientific capabilities.
Company
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.
Profile
Education:
* Bachelor’s degree, secondary degree, or equivalent experience.
Skills and Competencies:
* Proficient understanding of GxP Quality Systems and relevant regulations (e.g., EU GDP/GMP, MHRA).
* Operational knowledge of electronic quality systems.
* Familiarity with Document Management Systems (TruVault/Veeva) is preferred.
* Excellent written and verbal communication skills, 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).
Offer
What We Offer:
* A rewarding position with excellent work-life balance; work 4 days per week (10 hours/day).
* A supportive and innovative work environment that fosters learning and personal growth.
* Opportunities to collaborate with colleagues from diverse backgrounds.
* Initial engagement through interim contracts, transitioning to a permanent contract after six months.
* 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.