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?
- Execute the QC tests transfer activities according to SOP procedure between our partner’s sites in Europe
- Draft, assign and support the following documents by co-building it with the experts, major stakeholder and if needed decision bodies; this includes the signature procedure:
- Test Transfer Plan (TTP) at the beginning of a project, or when required.
- Method Transfer Plans of the test transfer method protocols (via the AMTP/R (analytical method transfer protocol/report) process documentation).
- Change request between sending and receiving sites
- Use statistical tools and QC tests validation protocols/reports to:
- define the tests transfer criteria, in collaboration with QC statisticians, QC coordinators (GQC) and QA colleagues
- analyze the QC results obtained locally and write the AMTR (report) documents.
- Support the training coordination between donor and receiving sites
- Support the transfer strategy in resolving bottlenecks and showstoppers
- Draft publication for replacement and reduction of animal testing scientific. Act as key contact for all involved parties related to Data work and review.
- Draft abstracts, posters, presentations for external advocacy on the topic of replacement and reduction of animal testing.
- Perform conclusive Literature research and summarize in short briefings for Scientists and Senior Leaders
- Ensures documentation, minutes and reports are produced in a timely manner and are shred with major stakeholders and archived in line with the Company requirements.
Who are you?
- You hold a Scientific master’s degree
- You have minimum of 8 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
- Good written and oral presentation capability in 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] or +32497/51.50.9