Pharma

Pharma

Document Control Specialist - Quality Assurance

9052 ZWIJNAARDE
Optie vast contract
Secundair Onderwijs
35 h/semaine
2 600 - 2 800 €/mois
Postuler
Sauvegarder Retour

Description de fonction

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.

Profil

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).

Offre

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.

 

Information

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.

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Start People Inhouse Legend Biotech
+32 (0)93 377 999
legendbiotech@startpeople.be
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