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GMP & Operational Documentation Coordinator

  1. Brussels
Brussels
  1. Contract
Competitive
  1. CAPEX Projects
34488

This vacancy has now expired

GMP & Operational Documentation Coordinator - Brussels, Belgium - 12-Month Contract 

We are looking for an experienced GMP & Operational Documentation Coordinator for a fantastic 6-9 month contract based in Belgium.

You will be working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

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:
  • To oversee and to update the GMP & Operational documents tracker with most up-to-date information retrieved from EDMS (Electronic Document Management System – Veeva Vault / Source CD)
  • To update and to communicate dashboards with relevant KPI’s linked to GMP & Operational documentation, including the interpretation of the indicators and their translation into recommended actions by the Genesis GMP & Operational Readiness initiative Sponsor, the Genesis Project Manager, and the Channels Leaders
  • To contribute to the continuous improvement of the documents tracking tool and the associated documents preparation and delivery practices
  • To escalate risks and issues related to the GMP & Operational documents preparation and approval to the Genesis Project Manager and to the different stakeholders
  • 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)
  • 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:
  • Experience in a GMP Biopharma Manufacturing or Engineering CAPEX Project related to bioprocessing
  • Proven experience in the field of Documentation Management and Project Management
  • Experience with MS Office; knowledge of Veeva Vault EDMS is an asset
  • Excellent leadership, negotiation, collaboration, and management skills.
  • Excellent interpersonal and conflict resolution skills will be required, as the role works frequently in a resource challenged and schedule sensitive environment
  • Excellent communication and presentation skills with the ability to effectively communicate ideas, goals, and results to various audiences.
  • Special knowledge requirements include biopharmaceutical processes and operations, plus a solid understanding of cGMP requirements.
  • Demonstrated strong spreadsheet and database management skills is necessary to process and present detailed technical data in a clear and concise manner
  • Ideally must speak English and French

If this role is of interst to you, please apply now! 

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