Project Assistant Farma

BeerseIFarmaceutische industrie

Functieomschrijving

GENERAL MISSION

  • The Outsourcing Coordinator drives the design, packaging and labeling of high quality clinical supplies for studies worldwide, for external packaging through third-party contractors.
  • He/she uses his/her expertise in design, labeling and packaging execution to convert the needs of the clinical demand into compliant packaging designs.
  • He/she takes the lead and ownership of the Operational meeting to ensure all the deliverables are met to achieve GMP release on time.

 

SPECIFIC MISSIONS

  • Ability to help manage a complex compound portfolio (for example: pooled studies, accelerated timelines, high tech devices, frozen platform, products that require exceptional packaging processes and storage conditions, …).
  • He/she supports the lead Outsourcing Coordinator with the Operational meeting to review packaging orders to ensure all the deliverables are met to achieve GMP release on time. He/ she will work with the lead Outsourcing Coordinator or directly with the TSM and take the lead in communicating with all other functions within CSC about on time delivery, required actions and status of the P&L orders. He/she will learn how to escalate potential missed timelines through this meeting and determine possible solutions to minimize impact.
  • Learn to manage projects with packaging vendors, negotiating timelines, overseeing project progress to ensure timely release and distribution of the clinical material to depots
  • Develop strong internal collaboration within the CSC and begin influencing stakeholders to improve services, cost or lead time.
  • Create and maintain individual project agreements (IPA) between CSC and P & L vendors.
  • Indicate label needs on the sharepoint site enabling the Label Coordinators to start preparing the label design in a timely manner.
  • Review and approve relevant parts of source documentation (IMPA).
  • Maintain detailed knowledge of packaging designs, components, label requirements, randomizations, systems, end-to-end processes, regulatory, GCP and GMP requirements.
  • Support the Lead Outsourcing Coordinator with training of P & L OC new hires on the outsourced P&L processes within outsourcing coordinator functions and team members of the operational meeting.
  • Attain expertise of packaging designs, label process, label requirements and packaging execution. Understand how to influence the IMPA owner 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
  • Participate actively in global initiatives to optimize processes and tools in line with the Process Excellence Methodology.
  • Develop compliant, user-friendly packaging designs in conjunction with the P & L vendors, and internal partners in accordance with the trial design
  • Utilize the randomization specifications to create 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. Manage packaging orders in SAP and NGEN CODAC.
  • Communicate finished goods details (e.g. quantity, ranges, etc) to the Clinical Design Integrator or the Trial Supply Manager.
  • Support the Lead Outsourcing Coordinator with events, deviations and CAPAs and implement process improvements (route cause analysis, corrective and preventive actions, impact assessment, organize training, update SOPs)
  • Work with the Lead Outsourcing Coordinator to conduct issue resolution activities for P & L aspect of clinical studies.
  • Initiate and oversee outsourced packaging projects with external vendors:
    • ­Facilitate pre-and post-packaging approvals and obtain release through Quality Assurance.
    • ­Work as the Lead Outsourcing Coordinator as J&J’s primary point of contact for P & L vendors by maintaining good working relationships and communication with the contractor, other CSC functions, QA, AD and other business partners.
    • ­Responsible for vendor set up of the financial aspects including vendor quotes, PO’s and invoicing.
    • Assist periodically in monitoring contractor performance.
  • Participate in audits and audit preparedness in collaboration with QA and vendor if applicable.
  • Coordinate relabeling activities at sites and depots.
Profiel

KNOWLEDGE

  • Bachelor degree in scientific field or equivalent through experience. Generally, requires 3-5 years of related or relevant experience.
  • Knowledge of inventory management systems
  • 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)
  • Experience in clinical packaging and operations is preferred

 

COMPETENCIES

  • Result and performance driven
  • Project management skills
  • Big picture orientation with attention to details
  • Strong analytical skills managing complexity and identifying process gaps.
  • 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
Organisatie- en afdelingomschrijving

Select Projects maakt deel uit van een internationale full-service Human Resources-organisatie, Select. Select Projects is specialist in het aanbieden van oplossingen via projectsourcing.

Vanuit onze vestigingen in België, Nederland en Dubai bieden wij ondersteuning aan bedrijven die behoefte hebben aan ervaren specialisten/projectmedewerkers in verscheidene werkgebieden. We onderscheiden ons door onze goede opvolging en service naar al onze klanten en onze medewerkers.

Aanbod

Je krijgt een aantrekkelijk salarispakket met interessante extralegale voordelen. Een bedrijfswagen, maaltijdcheques, een groepsverzekering en gsm-abonnement behoren tot de mogelijkheden.

Wij zorgen ervoor dat je in een aangename werkomgeving terecht komt met leuke collega’s en mogelijkheden om je te ontplooien en verder te ontwikkelen. Zo stippelen we samen met jou een opleidingstraject uit op maat van jouw toekomstplannen en behoeften op dit moment.

Heb je nog vragen?
Sakina El Kasmioui Sourcer Select Projects +32 3 203 50 89
Project Assistant Farma Vacature informatie
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