Documentation & Compliance Officer- Biosimilar

Job Scope:

The Documentation & Compliance Officer is responsible for managing, organizing, and ensuring the compliance of regulatory, quality, and GMP documentation in order to guarantee adherence to legal and regulatory requirements at the biosimilar site. The role ensures document integrity, traceability, audit readiness, and full alignment with GMP and applicable regulatory standards.

Job Requirements:

Education: Bachelor’s or master’s degree in: Pharmacy, Biotechnology, Laboratory Sciences Pharmaceutical, Quality Document Management or related field.

Experience: At least three years on compliance, QA, in pharma.

• Languages: Fluent Arabic, English & French 

Technical Knowledge :

• Strong knowledge of GMP documentation management (SOPs, batch records, protocols, validation reports).
• Knowledge of regulatory requirements (ANPP, WHO, ISO 9001 / 14001 / 45001).
• Good archiving practices and document traceability.
• Understanding of pharmaceutical audits and inspections.

Personal Traits:

·        High level of rigor and organization.

·        Strong attention to detail and analytical mindset.

·        Good communication and cross-functional collaboration skills.

·        Ability to work under pressure and meet deadlines.

Duties and Responsibilities:

·        Organize, control, and archive quality and regulatory documents (SOPs, batch records, validation protocols and reports, certificates).

·        Ensure proper document versioning, traceability, and availability for all departments.

·        Prepare and maintain regulatory files and ensure audit readiness.

·        Ensure compliance with GMP standards and applicable ISO and regulatory requirements.

·        Verify the documentary compliance of Production, QC, QA, Engineering, and Validation activities.

·        Participate in internal audits and support external inspections.

·        Prepare required documentation for audits and regulatory inspections.

·        Ensure availability and accuracy of documentary evidence.

·        Follow up on corrective and preventive actions (CAPA) after audits.

·        Monitor the proper implementation of SOPs and work instructions.

·        Verify the correct completion of forms and records.

·        Identify documentation gaps and propose corrective actions.

·        Train and raise awareness among teams on proper documentation practices and compliance.

·        Provide guidance on regulatory requirements and document management best practices.

·        Collaborate closely with QA, QC, Validation, Production, and HSE to ensure document integrity.