Batch record coordinator

BeerseIFarmaceutische industrie

Functieomschrijving

As an Batch Record Coordinator you are responsible for: 

  • Ability to manage complex compound portfolio (for example: pooled studies, high tech devices, frozen platform,…).
  • Conduct review of source documentation and packaging records and provide feedback as learning opportunity for peers and technical team members.
  • Maintain detailed knowledge of packaging designs, components, label requirements, randomizations, systems, end-to-end processes, regulatory requirements and GMP know how. 
  • Coordinate NIMP (non investigational medicine product) label printing to ship to depots
  • Act as an expert in the Technical Team on packaging designs, label process, label requirements and packaging execution. Influence the team in taking decisions in line with packaging standards and processes. Act as a single point of contact between the team, the Label Coordinator, the Packaging operations unit and the Process and System Technician.
  • Constantly strive for automation and innovation in order to help increase efficiency and reduce timelines. Participate actively in global initiatives to optimize processes and tools in line with the Process Excellence Methodology.
  • Develop compliant, user-friendly packaging designs in accordance with the trial design. Evaluate the need for, initiate and coordinate new tool and carton designs in consultation with the Process and System Technician.
  • Translate randomization specifications into project specific kit lists. Ensure the generated files are transferred to the necessary recipients.
  • Convert all data with regards to the trial design, packaging design, labeling and randomization into packaging element trees and kit assembly flows.
  • Develop a workload planning driven by constant changes in priority. Closely follow up on milestones contributing to timely availability of all data required to finalize packaging order entry. Clearly indicate label needs on the Sharepoint enabling the Label Coordinators to start preparing the label design in a timely manner.
  • Maintain strong collaborations and relationships with the Technical Team, the Supply Chain Planners, the Label Coordinators and the Packaging operations unit to ensure last-minute changes or issues can be handled adequately.
  • Manage events, deviations and CAPA's and implement process improvements (route cause analysis, corrective and preventive actions, impact assessment, organize training, update SOPs)
  • Engage on audits and audit preparedness in collaboration with QA and vendor if applicable.
Profiel

As Batch Record Coordinator you can/have: 

  • You have a Bachelor Degree or Equivalent (Requirement)
  • You have project management skills
  • You are strong analytical skills managing complexity and identifying process gaps.
  • You have experience in clinical packaging and operations is preferred
  • Strong organizational skills
  • Ability to communicate complex issues and solutions to business partners
  • Influencing and negotiating skills
  • Ability to work in cross a functional and cross cultural environment
  • Knowledge of inventory management systems
  • You have experienced in GMP, GCP, GDP and or quality management systems or processes.
  • Knowledge of planning systems and contractor project plans
  • Knowledge in Office applications (MS Word, MS Excel, MS PowerPoint)
Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Aanbod

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Heb je nog vragen?
Marlies Collart Human capital developer Select Projects +32 3 203 50 80
Batch record coordinator Vacature informatie
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