Specialist QC Transfer
Brabant Wallon – contracting
#QC #Transfer #Pharma
Our partner is looking for a Specialist QC Transfer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will Coordinate the transfer of QC activities to other sites. Here are your main activities :
- Organize the transfer of QC analytical tests to our partner’s sites (or to external collaborators) located abroad, up to the routine commercial operations (PPQ consistency lots)
- Support Project Teams and Steering Committees 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. Build the specific Tech Transfer documentation (TTP/R, AMTP/R, RTP)
- 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.
- Be the SPOC to our trainees/collaborators for all the QC tests transfer aspects
- Participate to the writing of Project Charter (PC) and/or a Test Transfer Plan (TTP) at the beginning of a project, or when required.
- Participate to the writing of the test transfer method protocols (via the AMTP/R process documentation).
- Use statistical tools and QC tests validation protocols/reports to define the tests transfer criteria, in collaboration with QC statisticians, QC coordinators and QA colleagues.
- Analyze the QC results obtained locally and write the AMTR (report) documents.
- Ensure compliance of the projects and processes with existing standard policies and procedures by taking local authorities/requirements into account
- Organize the TCO (Transfer Close Out) meetings with GQC to validate the hand-over of the projects
- Ensure a close follow-up of the QC activities via regular teleconferences by providing adequate technical support
- During the transfer phase, set-up and maintain a database to compile the reagents requests and follow-up the shipments
- Participate and present the advancement of their projects to project teams and to staff meetings, when required.
- 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…).
Who are you?
- You hold a Scientific master’s degree
- You have minimum of 5 years of proven experience in setting up & leading successful method transfers within the pharmaceutical industry
- You have Scientific and Analytical background of the “in vitro” and “in vivo” QC analytical methods
- You are a good team player with communication skills and a diplomacy approach when dealing with colleagues within or outside the organization
- You are fluent in french and English
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected]
