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QC Specialist Transfer

Eingestellt von Harvey Nash BE

Gesuchte Skills: Support, Engineering

Projektbeschreibung

Specialist QC transfer

FUNCTION DESCRIPTION
One consultant for QC Analytical Methods transfer of activities from Belgium to other external collaborators.

KEY RESPONSIBILITIES
The incumbent of this position has to :
* Collaborate with people located in QC department and abroad. Convince them vis-à-vis company decisions, procedures or processes, while remaining diplomatic and maintaining motivation.
* Organize the transfer of knowledge between site in collaboration with QC department (Physicochemistrycollect data, procedure, validation documentation
* Participate/help QC analytical method specialist for the effective transfer of practices to external Vaccines entities.
* Contribute to the master planning of transfer
* Be able to manage internally (between colleagues from different departments) as well as externally good contacts with people in order to get the necessary information and respect the timings of the projects.
* Participate on risk assessment on method to be transferred at each stage of the production
* Request 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.
* Be able to manage short term issues with long term activities in parallel.
* Diagnose process /QC technical problems and report them to the upper management.
* Develop networking relationship and be able to operate cross-functionally.
* Produce cGMP-compliant analytical method transfer documents: Participation on the writing of protocol and report of transfer
* Establish strategy for methods to transfer in collaboration with supervisor in charge of the method and linked with the lab technicians in charge of the method
* Ensure a close follow-up of the QC activities by providing adequate technical support (responses to questions, documentation & SOPs transfer, SOP explanation/translation/clarification, etc.. ) during the QC tests transfer process, in collaboration with QC commercial department (GQC)

PREREQUISITES
Education
* Scientific/Engineering degree (minimum BAC+4) ( Chemist or biochemist)
Knowledge
* Bilingual French/English (oral & writing)
* Statistical skills is an asset
* Good communication and negotiation skills
* Ability to work under pressure due to the requested flexibility and reactivity of the activities
* Autonomous
* Hands-on mentality
* Ability to work in project teams in a multidisciplinary environment and a matricial organization
Experience
* Experience in (bio)pharma & cGMP is an asset.
* Experience in (bio)physicochemical techniques (HPLC, colorimetric assay, ELISA…) is an asset.

TRAINING PERIOD
1 to 3 months "on the floor training/coaching" is anticipated for this position

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash BE