VALIDATION QUALITY/PROJECT ENGINEER. HF

Job description

Entreprise:
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with 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.
Essential Duties and Responsibilities:
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.
- 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