Pharma

Pharma

Document Control Specialist - Quality Assurance

9052 ZWIJNAARDE
Optie vast contract
Secundair Onderwijs
35 u/week
2.600 - 2.800 €/maand
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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

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.

 

Bedrijfsinfo

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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