VALIDATION QUALITY/PROJECT ENGINEER AG HF

Job description

BELGIQUE(Lessines)
du01 juillet 2020au01 juillet 2021(pour12mois)
ETABLISSEMENT :BAXTER SAS
REMUNERATION MENSUELLE :1809€ (indemnité non contractuelle fixée par décret et arrêté, dont le montant peut varier notamment en
fonction de l’évolution du barème de référence, de la localisation de la mission et des cas d’abattements prévus par les textes)

BAXTER:

Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide

Role and responsabilities

Coordinate and support validation activities working closely with QA, PSM, Engineering, IT, Automation, Production and R&D departments.

-Act as a validation representative for projects that include validation activities:
- Participate on the validation methodology and approach for the project.
- Provide validation expertise and quality assurance guidance for the development of the project: direct involvement in the definition of the process/system specifications.
- Provide a support of the facility change control process.
- Participate of the process periodic evaluation (protocol/report redaction and organization with process user)
- Prepare and implement FAT, IQ, OQ, PQ, process validation protocols.
- Assure traceability throughout the whole project validation file (from URS to PQ).
- Organize and coordinate FAT, IQ, OQ, PQ, Process validation activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader.
- Analyze, interpret, document and report the testing results.
- Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system.

Profile:
-Engineer, bachelor with experience or traineeship in validation, QA
-Good knowledge of current European and FDA regulations
-Good Communication skills
-Good problem solving and critical thinking skills
-Good knowledge in statistical analysis
-Good knowledge of English
-Versatility, autonomy, rigor and reactivity