GMP Operationnal Documentation coordinator

il y a 3 jours

Brainel'Alleud, Belgique Randstad Travail à distance Freelance Temps plein

We are looking for a GMP Operationnal Documentation coordinator for one of our clients in the pharmaceutical sector based in Braine-lâAlleud.

Don't hesitate to contact me : delphine.vanriet@professionals.randstad.be

This is a consultancy contract to start in June and to end on December 31, 2024

key responsibilities

The GMP Operationnal documentation Coordinator main tasks are:

⢠To oversee and to update the GMP & Operational documents tracker with most up-to-date information retrieved from our customer's EDMS (Electronic Document Management System â Veeva Vault / Source CD)

⢠To update and to communicate dashboards with relevant KPIâs 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

⢠To promote and to contribute to the overall project team collaboration within the GMP & Operational Readiness initiative

⢠To influence and to negotiate with project team members and project stakeholders to gain alignment and win concessions without damaging relationships

⢠Perform work in compliance with all applicable corporate standards

qualifications

For the position of GMP Operationnal Documentation Coordinator, we expect the below competences and expertise:

  • 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 
  • Fluent in French & professional English is a must

    key benefits

    For this position of GMP Operationnal Documentation coordinator we offer the below package:

    • An attractive salary and below benefits:

      Work life balance: 

      Enjoy a hybrid work environment with the option to work remotely.

      Contributions to your healthy and security:

      • Group Insurance to secure your future.

      • Hospitalization Insurance for your peace of mind.

        Extra-Legal Benefits:

        • Meal Vouchers worth 7 euros gross per working day. 

        • Transport Reimbursement or a company car option, to ease your travels. 

        • Monthly Allowance of 80 euros net. 

        • 13th Month Bonus  

          Development Opportunities: 

          Access ongoing training to boost your career and stay at the forefront of innovation.

          For Freelancers: we offer an attractive daily rate



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