QC Transfer Specialist
Walloon Brabant – Consultance
#project #QC #transfert #innovation #laboratory
Are you interested in the pharmaceutical industry and putting your knowledge of project management to good use?
Our client is actively looking for a QC Transfer Specialist to strengthen its activities. Our partner is active in the pharmaceutical sector.
What are your responsibilities?
As QC Transfer Specialist, you are in charge to
- Coordinate the QC tests transfer activities between Belgium Sites and the other sites and to other external collaborators.
- Organize the QC trainings of our partner and external collaborators from different sites (located abroad).
- 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.
- Organize the transfer of QC analytical tests to our sites (or to external collaborators) located abroad.
- Supports project teams and steering committees 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.
- Participate to the writing (+ sign) of the test transfer method protocols. Use statistical tools and QC tests validation protocols/reports to define the tests transfer criteria.
- Participate to the writing of Project Charter (PC) and/or a Test Transfer Plan (TTP) at the beginning of a project, or when required.
- Analyze the QC results obtained locally and write the AMTR (report) documents.
- Ensure compliance of the projects and processes with existing our partner’s standard policies and procedures by taking local authorities/requirements into account (GMP practices to be followed).
- Organize the TCO (Transfer Close Out) meetings with GQC, in order to validate the handover of the projects to GQCCoE.
- Ensure a close follow-up of the QC activities by providing adequate technical support for the sites, during the QC tests transfer process, in collaboration with QC commercial department.
- Build his network within Belgium QC laboratories, in order to guaranty the adequate support for QC tests methods to be transferred locally. Pay attention to the harmonization of the methods between sites during transfer.
- During the transfer phase, set-up and maintain a database to compile the reagents requests and follow-up the shipments to the site or collaboration sites: ensure the right QC reagents management between both sites (selection of samples and quantities required, and follow-up of the shipments process) in collaboration with the QC commercial department.
- Participate in preparation of the meetings (slides) for their N+1 (Steering committee, Advisory board, etc…).
- Participate and present the advancement of their projects to project teams and to staff meetings, when required.
- Participate in change initiatives involving Product Transfer team (Process harmonization, QC samples management process improvement, documentation, ways of working, or other specific PTT working groups, etc…).
- In setting and continuously reviewing QC tests transfer progress, according to the global project plans.
Who are you?
You are graduated as a PhD/Master degree in Science. Your experience in the biotechnology / pharmaceutical industry. You have knowledges in QC. You fluently speak English.
What can you expect?
A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.
You’re interested in this job? We kindly invite you to apply directly on our website www.jeffersonwells.be.