GMP & Operational Documentation Coordinator
We are looking for an experienced GMP & Operational Documentation Coordinator for a fantastic 6 month contract based in Brussels.
Working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will have the oversight on all documents to be updated or created by transversal contributors, in the scope of the GMP & Operational Readiness initiative within the project
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities:
1. To oversee and to update the GMP & Operational documents tracker with most up-to-date information retrieved from EDMS
2. To contribute to the continuous improvement of the documents tracking tool and the associated documents preparation and delivery practices
3. To escalate risks and issues related to the GMP & Operational documents preparation and approval to the Genesis Project Manager and to the different stakeholders
4. In collaboration with the Genesis Project Manager and the Project Planner, to monitor the GMP & Operational documents delivery progress against the baseline timeline, to flag and escalate schedule variances, and to anticipate the risk of documents delivery delays by proposing mitigation plans (incl. appropriate allocation of resources and definition of priorities)
5. To drive the GMP & Operational documents delivery process through proactively and closely collaborate with all stakeholders, incl. documents owners, reviewers an approvers and their managers, if needed
Requirements:
6. Extensive Experience in a GMP Biopharma Manufacturing or Engineering CAPEX Project related to bioprocessing
7. Proven experience in the field of Documentation Management and Project Management
8. Experience with MS Office; knowledge of Veeva Vault EDMS is an asset
9. Excellent interpersonal and conflict resolution skills will be required, as the role works frequently in a resource challenged and schedule sensitive environment
10. Fluent in French & professional English is a must
If this role is of interest, please apply now.