Technical Writer (GMP Documentation) M/V/X

Description de la fonction

The Technical Writer will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR-T Operations and document lifecycle management. They will also be responsible to prescribe the correct training based on the type of changes made.

Major Responsibilities:

• Oversight of the revision process of existing SOPs in time to support Manufacturing Strategy.
• Oversight of the introduction of new SOPs in time to support Manufacturing Strategy.
• Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.
• Ensure proper training is prescribed as per the document changes made.
• Liaison with Operations, Technical Operations and QA to ensure alignment of changes.
• Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
• Stay current regarding industry standards and ensure that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.
• Support development and roll out of an electronic batch record.
• Track relevant KPIs.
• Ensure periodic log book reviews are complete.
• Ensure periodic review of all GMP documents are completed on time.

Profil

• Degree in Scientific discipline or equivalent work experience
• 3-5 or more years of related experience in cGMP/FDA regulated industry is preferred
• Pharmaceutical GMP's - strong knowledge of Good Manufacturing Practices and regulatory knowledge is a required
• Must be Proficient in MS Office applications and other related IT Systems.
• Knowledgeable in electronic Document Repositories and LMS (Learning Management Systems)
• TrackWise knowledge is a plus

Compétences linguistiques

• Anglais (atout)

  • Comprendre : Indépendant - (B1)
  • Écrire : Indépendant - (B1)
  • Lire : Indépendant - (B1)
  • Parler : Indépendant - (B1)

• Néérlandais (atout)

  • Comprendre : Elémentaire (A)
  • Écrire : Elémentaire (A)
  • Lire : Elémentaire (A)
  • Parler : Elémentaire (A)

Avantages du poste

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contract of indefenite duration, included:

• Company car + fuel card
• Health insurance
• Meal vouchers of 8€ per day worked
• Net allowances
• Group insurance
• Smartphone subscription
• End of year bonus (13th month)
• Eco vouchers

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