Documentation Officer - Biosimilar

About the role

The Documentation Officer will manage and control all production‑related documentation for biosimilar products, ensuring strict compliance with company procedures, quality standards, and regulatory requirements. This position plays a key role in supporting continuous improvement and operational excellence within the production department.

Key responsibilities

• Define, write, and update Standard Operating Procedures (SOPs) and technical documents for the Production Department in line with GMP and internal standards.
• Participate in the standardisation of practices and the enhancement of technical documentation.
• Develop, monitor and analyse Production Department Key Performance Indicators (KPIs).
• Support continuous improvement projects and operational excellence initiatives.
• Contribute to investigations, root‑cause analysis and the implementation of Corrective and Preventive Actions (CAPA).
• Ensure compliance with HSE rules, industrial safety standards and applicable pharmaceutical regulations.
• Collaborate with cross‑functional teams to plan and monitor production schedules.
• Assist in internal audits, regulatory inspections and departmental meetings.
• Follow up on production staff training plans and maintain training records.

Required profile

• Engineer’s or Master’s degree in Biology, Chemical Engineering, Process Engineering or a related field.
• Minimum 2 years of experience in a similar role, preferably within the pharmaceutical industry.
• Strong organizational abilities and a results‑oriented mindset.
• Excellent written and oral communication skills in French and English.

Required skills

• Good knowledge of GMP requirements.
• Understanding of ISO 9001 standards.
• Proficiency with Microsoft Office software.