DescriptionWe 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.
CompanyOur 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. ProfileEducation:
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).
OfferWhat 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.