GMP-Driven Production Documentation Specialist

Jubilant Pharma, LLC; Caen; Presencial; EUR 32 000 - 42 000; Tempo integral

Resumo da oferta

Jubilant Radiopharma in Caen, France is seeking a Production Documentalist to ensure accuracy, completeness, and compliance of manufacturing documentation. You will coordinate, review, and manage documentation across Production, Quality Control, and Quality teams.

The role emphasizes adherence to GMP, batch record review, and continuous improvement. Proficiency with MS Word, SAP, and Excel is required, along with strong attention to detail and teamwork.

Qualificações

• Experience in pharmaceutical production.
• Knowledge of GMP is an asset.
• Proficiency with Microsoft Word, SAP, and Excel.
• Fluent communication in English and French to use English-only systems.

Responsabilidades

• Coordinate and distribute documentation related to manufacturing batches following production activities.
• Monitor orders within company systems to support timely delivery and a just-in-time production environment.
• Print and prepare documentation required for production operations.
• Verify printed documents and ensure their release by the Quality team.
• Ensure adherence to good documentation practices.
• Review and approve batch records and GMP documentation, including logbooks, AWOs, registers, and other GMP-related documents.
• Contribute to continuous improvement of documentation and batch record review processes.
• Prepare weekly KPI reports related to documentation performance within Operations and Quality Control.
• Partner with Quality to support document management and archiving activities.
• Collaborate with the Production Supervisor to improve documentation accuracy and right-first-time performance.
• Perform other related duties as required to support operations.

Conhecimentos

Manual dexterity

Attention to detail

Strong communication

Teamwork

Microsoft Word

SAP

Excel

Ferramentas

Microsoft Word

SAP

Excel

Descrição da oferta de emprego

Jubilant Radiopharma in Caen, France is seeking a Production Documentalist to ensure accuracy, completeness, and compliance of manufacturing documentation. You will coordinate, review, and manage documentation across Production, Quality Control, and Quality teams.

The role emphasizes adherence to GMP, batch record review, and continuous improvement. Proficiency with MS Word, SAP, and Excel is required, along with strong attention to detail and teamwork.