Quality Control

Il y a 2 mois

Brainel'Alleud, Belgique Capgemini Engineering Temps plein

**_Your Responsibilities _**
- **_Coordinate the Quality Control (QC) tests transfer activities between different Manufacturing sites and between a site to other external collaborators (CMO) up to the routine commercial operations _**
- **_Be the SPOC (Single Point Of Contact) for all the QC tests transfer aspects in collaboration with the Manager of the project _**
- **_Ensure a close follow-up of the QC activities by providing adequate technical support during the QC tests transfer process, in collaboration with QC commercial department _**:

- **_Supports Project Teams 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 _**:

- **_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 _**:

- **_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 _**:

- **_Build the specific Tech Transfer documentation;
- document these analytical transfers according to the predefined rules/SOP _**
- **_Participate to the writing of 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 and QA colleagues _**
- **_Analyze the QC results obtained locally and write the final report document _**
- **_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 )
- **

**_Basic Qualifications _**
**_We are looking for professionals with these required skills to achieve our goals: _**
- **_University degree with scientific background (biology, chemistry, pharmacy,), or minimum 5 years of experience in the pharmaceutical industry (preferably with QC tests related background) _**:

- **_Fluent in French or Dutch and English (spoken and written) _**:

- **_Good communication and negotiation skills and diplomacy approach when dealing with colleagues within or outside the organization (in Belgium and abroad) _**:

- **_Good technical writing and teaching skills, good computer skills _**:

- **_Scientific background of the “in vitro” “in vivo” QC analytical methods is a plus_

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