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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
Capacity: 5 days per week
Location: Braine and remote (up to 60% remote)
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