Production Documentalist

Jubilant Life Sciences; Caen; On-site; EUR 32,000 - 42,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Manual dexterity

Attention to detail

Strong communication

Teamwork

Microsoft Word

SAP

Excel

Tools

Microsoft Word

SAP

Excel

Job description

At Jubilant Radiopharma, we help support patient care through the manufacturing and distribution of high-quality radiopharmaceutical products. Our success is built on talented people, collaboration, and a commitment to excellence.

We are looking for a detail-oriented and organized Production Documentalist to join our team. In this role, you will help ensure the accuracy, completeness, and compliance of critical production documentation.

Role Overview

The Production Documentalist is responsible for coordinating, reviewing, and managing manufacturing documentation. Working closely with Production, Quality Control, and Quality teams, this role helps maintain documentation integrity, supports compliance with good documentation practices, and contributes to continuous improvement initiatives.

Key Responsibilities

• 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.

Qualifications

• Experience in pharmaceutical production.
• Manual dexterity, strong attention to detail, and ability to maintain concentration.
• Strong communication and teamwork skills.
• Knowledge of Good Manufacturing Practices (GMP) is an asset.
• Proficiency with Microsoft Word, SAP, and Excel.
• Knowledge of spoken and written French and English to use systems that are available only in English.