Documentation Officer - Biosimilar

Job Scope:

The Documentation Officer is responsible for managing, controlling, and maintaining all production-related documentation to ensure compliance with company procedures, quality standards, and regulatory requirements.

Job Requirements:

• Education: Engineer's or master’s degree in biology, Chemical Engineering, Process Engineering or a related field.

• Experience: Minimum of 2 years of professional experience in a similar position, ideally in the pharmaceutical industry.

• Professional Knowledge:

 - Good knowledge of GMP requirements and ISO 9001 Standards.

- Proficiency in Office Software.

- Ability to write technical and documentation documents.

- Strong organizational skills and ability to work effectively in a team.

- Results-oriented and committed to continuous improvement.

- Good written and oral communication skills in French and English.

Duties and Responsibilities:

- Define, write, and update the Production Department's documentation system, including Standard Operating Procedures (SOPs) and technical documents in accordance with GMP requirements and internal procedures.

- Participate in the standardization of practices and the improvement of technical documentation.

- Develop, follow-up and analyse the Production Department's Key Performance Indicators (KPIs).

- Participate in continuous improvement and operational excellence projects.

- Contribute to the investigations and root cause analysis, as well as the implementation of Corrective and Preventive Actions (CAPA) and all QMS Production related documents.

- Ensure compliance with HSE rules, industrial safety standards, and applicable pharmaceutical regulations.

- Collaborate with various departments to establish and monitor the production activity schedule.

- Participate in internal audits, regulatory inspections, and periodic department meetings.

- Ensure the follow-up of the Production staff training plan and training files in accordance with the Training / Compliance department.