Documentation Officer – Biosimilar

About the role

The Documentation Officer will manage and maintain all production‑related documentation for biosimilar products, ensuring strict compliance with GMP, ISO 9001, and internal quality standards. You will work closely with the Production Department to create, update, and control technical documents.

Key responsibilities

• Define, write, and update SOPs and technical documents for the Production Department in line with GMP requirements.
• Standardize practices and improve the technical documentation system.
• Develop, monitor, and analyse Production KPIs.
• Support continuous‑improvement and operational‑excellence projects.
• Participate in investigations, root‑cause analysis, and implement CAPA and related QMS documents.
• Ensure compliance with HSE rules, industrial safety standards, and pharmaceutical regulations.
• Collaborate with cross‑functional teams to schedule production activities.
• 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 knowledge of GMP requirements and ISO 9001 standards.
• Proficiency with office software and ability to produce clear technical documentation.
• Excellent written and oral communication skills in French and English.

Required skills

• GMP compliance
• ISO 9001 standards
• Microsoft Office suite
• Technical writing
• KPI development and analysis
• CAPA implementation
• QMS documentation management