Document and Records Management Expert (M/F/D)
Tasks:
* Perform quality control on non-clinical documents (protocols, amendments, reports, etc.).
* Ensure compliance and document readiness for regulatory submissions.
* Upload, index, and track documents in the Veeva Vault EDMS.
* Oversee the document lifecycle, ensuring adherence to quality standards and GLP requirements.
* Liaise with stakeholders (authors, QA, RA, etc.) for follow-up on corrections and approvals.
* Provide training and guidance to internal users on good documentation practices.
* Participate in process reviews and continuous improvement initiatives for documentation workflows.
Qualification:
Must-Haves
* Minimum 8 years of experience in the pharmaceutical industry.
* Solid background in regulated documentation management (GLP, GCP, etc.).
* Deep understanding of non-clinical documentation and its lifecycle.
* Hands-on experience with Electronic Document Management Systems (EDMS), preferably Veeva Vault.
* Familiarity with regulatory expectations for submission-ready documents.
* Strong digital literacy.
* Comfortable working in high-compliance, traceability-focused environments.
Nice-to-Haves
* Prior experience in non-clinical / preclinical environments.
* Exposure to QA or regulatory affairs.
* In-depth GLP knowledge.
* Scientific background (biology, chemistry, etc.).
* Understanding of French is a plus (for informal/team interactions).
* Familiarity with other document management tools.
Requirements:
Start: 05.05.2025
Duration: 8 months
End: 31.12.2025
Capacity: 5 days per week
Location: Braine and remote (up to 60% remote)