Pharma

Pharma

Document Control Specialist - Quality Assurance

9052 ZWIJNAARDE
Optie vast contract
Secundair Onderwijs
38 h/semaine
2 600 - 2 900 €/mois
Postuler
Sauvegarder Retour

Description de fonction

We are seeking a dedicated Document Control Specialist to oversee and enhance the document management processes within our cell therapy manufacturing facility, catering to both clinical and commercial needs in a sterile, GMP-compliant environment. This role is pivotal in ensuring adherence to document management standards, proper storage, retention, issuance, and reconciliation of documentation.

Tasks:

  • Oversee and refine the document control systems and procedures for the facility.
  • Act as a reviewer for new and updated procedures and documents, ensuring alignment with global and site-specific standards.
  • Assist users with document management workflows and electronic systems.
  • Manage the regular review cycle for procedures.
  • Issue batch-related documentation to support GMP manufacturing operations.
  • Ensure GMP documentation is reconciled according to lifecycle requirements.
  • Develop and distribute GMP logbooks.
  • Handle the storage and archival of GMP documents and batch records.
  • Execute tasks in compliance with safety policies, quality systems, and cGMP standards.
  • Review and validate SOPs and other critical documentation.
  • Promote continuous improvement initiatives.
  • Utilize advanced computer skills to boost departmental productivity and expand technical and scientific expertise.

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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