ENGINEER QUALITY - BAXTER H/F

Job description

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 Responsibilities:
- 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.
- Participate in the risk assessment related to the project.
- Participate of the URS, FS and DS review for validation requirements and all applicable QA requirements.
- Participate in the determination of process or system controls.
- 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.
- Benchmark of compliance program, inside and outside the company
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