Specialist QC transfer - 92848

Interested ? Don’t hesitate to take a look at the job description below and feel free to contact me !

megane.libert@professionals.randstad.be

• 
  University degree with scientific background or minimum 5 years of experience in the pharmaceutical industry (preferably with QC tests related background)
• Perfectly fluent in French and English (written and spoken)
• Scientific background of the "in vivo" and ’in vitro" QC analytical methods
• Good communication and negotiation skills and diplomacy approach when dealing with colleagues within or outside the organisation
• Good technical wiring and teaching skills, good computer skills

Consulting

Advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible

Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.

Provide support:

• 
  QC tests transfer projects impacting all sites
• Organising training support related to existing projects
• Coordinate the QC tests transfer activities between different sites (Belgium, Singapore, Marburg, Rosia, Marietta, St Amand,...) and between a site to other external collaborators
• Organise the QC trainings of our client 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
• Document these analytical transfers according to the predefined rules/SOP
• Coordination the transfer of QC activities to other sites
• Organise the transfer of QC analytical tests to sites (or to external collaborators) located abroad, up to the routine commercial operations (PPQ consistency lots) according to procedure
• Supports 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)
• Organise 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 single point of contact (trainees / collaborators) for all the QC tests transfer aspects in collaboration with the single point of contact of the project
• Participate to the writing of project charter and / or 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 coordinators and QA colleagues
• Analyse the QC results obtained locally and write the AMTR documents
• Ensure compliance of the projects and processes with existing standard policies and procedures by taking local authorities / requirements into account (GMP)
• Organise the TCO (transfer close out) meeting with GQC, in order to validate the hand-over of the projects to GQCCoE before edition of the TTR (test transfer report)
• Ensure a close follow-up of the QC activities via regular teleconferences by providing adequate technical support (responses to questions, documentation & SOPs transfer, SOP explanation / translation / clarification,...) for the sites (and external collaborations) during the QC tests transfer process, in collaboration with QC commercial department
• Build his network between sites (QC laboratories from Belgium and from other sites, like Marburg, Marietta, Rosia,...) in order to guaranty the adequate support for QC tests methods to be transferred locally
• During the transfer phase, set-up and maintain a database to compile the reagents requests and follow-up the shipments: ensure the right QC reagents management between 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,...)
• Participate and present the advancement of their projects to project teams and to staff meetings, when required
• Participate in change initiatives involving test transfer team (process harmonisation, QC samples management process improvement, documentation, ways of working, or other specific TT working groups, etc...)