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Ensure compliance of computerized systems used in the Sterile Drugs and Plastic departments through the establishment GMP compliant validation.
Essential Duties and Responsibilities
Act as a validation representative for projects and periodic evaluation that include computerized system validation :
Define 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.
Review URS, FS and DS for validation requirements and all applicable QA requirements. Participate in the determination of process or system controls.
Participate as part of the project team in the definition of the user requirements and functional specifications of automated processes
Prepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirements
Prepare and implement FAT, IQ, OQ & PQ Protocols.
Assure traceability throughout the whole project validation file (from URS to PQ).
Organize and coordinate FAT, IQ, OQ, PQ 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.
Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal procedures
Approve tests sheets as QA reviewer.
Participate in the writing of specifications and SOP’s related to automated manufacturing processes
Maintain the validated state through the change control process : analysis of changes, definition of tests to be performed and approval of results
Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system.
Maintain the validated state through the periodic evaluation process
Develop procedures in compliance with Corporate and Industry requirements
Develop and deliver training to employees
Optimize the compliance program by showing expertise and leveraging resources with IS manufacturing and other shared services
Benchmark of compliance program, inside and outside the company
Develop and manage (re)validation program regarding the computerized systems
Participate in the communication of the good validation practices
Master in Engineering or Science or equivalent through experience
Number of years of experience : minimum 2 years in pharmaceutical industries
Field of expertise : Validation of Computerized Systems (GAMP) and automated processes or Validation activities with knowledge in computerized system
Knowledge of Pharmaceutical Industry requirements and English and French languages
Good knowledge of cGMP
Experience in validation
Good understanding of industrial processes and industrial control systems
Good knowledge of current European and FDA regulations
Relevant experience in Validation of Computerized Systems (GAMP)
Knowledge of Information and Automated systems
Good communication skills
Good problem solving and critical thinking skills