Process Quality Assurance

2 settimane fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary

Process Quality Assurance & SW Validation Engineer ensures that all manufacturing processes and supporting Computer systems are approved and validated, as well as facilities and equipment, producing a product that fulfills all the applicable internal and regulatory requirements.

#Thisiswhere you can grow in our Quality Assurance Team in Medolla

What you'll do

Evaluate the change request and compile the impact assessment for QA/QC area for the Process and Design Change Control; compile the execution and implementation phases ensuring it is correctly addressed; Assure that new or modified processes, Computer Systems and Automated Excel Spreadsheets and test methods are designed and validated in compliance with the Standards and internal Baxter Requirements, reviewing and approving related requirements and specifications documents; Define and document the validation strategy of Manufacturing Processes, Facilities/Utilities/Critical System, Computer System Validation and Automated Excel Spreadsheet, preparing validation plans and reports; Collaborate with different departments providing input for the compliance of the manufacturing processes, Software Systems and Operating Procedures.

What you'll bring

University degree in Engineering in Mechanical / Material / Chemical or related field, or equivalent degree; Previous experience in a similar role (better if in a medical devices company Knowledge of Applicable Quality System requirements, European Medical Device Directive 93/42/EEC and hemodialysis products are welcome; English knowledge (written, spoken, read); Ability to work in a team and problem-solving attitude; Good communication skills and ability to liaise with the different functions involved; Attitude to take ownership of assigned tasks from beginning to end;

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