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 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.

Profil

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.

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.

Intéressé(e) par cette offre d'emploi?

Postulez maintenant et nous vous contacterons prochainement.
Postuler Sauvegarder

Des questions?

Vous avez une question concernant ce poste? N'hésitez pas à nous contacter.

Start People Inhouse Legend Biotech
+32 (0)93 377 999
legendbiotech@startpeople.be
Demander un rendez-vous