Job Description

Your Responsibilities

1. Coordinate the Quality Control (QC) tests transfer activities between different Manufacturing sites and between a site to other external collaborators (CMO) up to the routine commercial operations
   
2. Be the SPOC (Single Point Of Contact) for all the QC tests transfer aspects in collaboration with the Manager of the project
   
   • Ensure a close follow-up of the QC activities by providing adequate technical support during the QC tests transfer process, in collaboration with QC commercial department
   • Supports Project Teams in setting and continuously reviewing QC tests transfer progress, according to the global project plans, milestones and timelines. Escalate issues if appropriate
   • Participate in establishing the Risk assessment specific for the QC tests activities, for all the projects involved
   • Organize the trainings of the external collaborators, required for the QC test methods transfer, in donor site premises, in collaboration with the QC commercial department
   • Request and coordinate the reagents shipments between sites to support the QC tests transfers, and provide support to lean the shipments process, in collaboration with QC and logistics departments
   • Build the specific Tech Transfer documentation,- document these analytical transfers according to the predefined rules/SOP
     
   • Participate to the writing of Test Transfer Plan at the beginning of a project, or when required
     
   • Participate to the writing of the test transfer method protocols. Use statistical tools and QC tests validation protocols/reports to define the tests transfer criteria, in collaboration with QC statisticians, QC and QA colleagues
     
   • Analyze the QC results obtained locally and write the final report document
     
   • Participate in change initiatives involving Tech Transfer team (Process harmonization, QC samples management process improvement, documentation, ways of working, or other specific TT working groups, etc…)
     

Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:

• University degree with scientific background (biology, chemistry, pharmacy, …), or minimum 5 years of experience in the pharmaceutical industry (preferably with QC tests related background)
• Fluent in French or Dutch and English (spoken and written)
• Good communication and negotiation skills and diplomacy approach when dealing with colleagues within or outside the organization (in Belgium and abroad)
• Good technical writing and teaching skills, good computer skills
• Scientific background of the “in vitro” “in vivo” QC analytical methods is a plus