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Process Quality Assurance

Req # JR - 022365 Location Thetford, England, United Kingdom Additional Locations 37.5 Job Category Quality Control Date posted 06/10/2020

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Summary

The Process QA will report to the Quality Lead working closely with production to test current products and identify deficiencies against local and global Quality Standards.

Essential Duties and Responsibilities

  • Test current products and identify deficiencies against local and global Quality Standards;
  • Suggest solutions to identified product problems
  • Investigate product quality in order to make improvements to achieve better customer satisfaction
  • Ensure continuous compliance of plant operations to GMP, local procedural requirements and Corporate policies
  • Support the QA team with batch specific investigations and product disposition in order to allow on time batch release
  • Support and lead problem solving investigations for product and process deviations and customer complaints
  • Responsible for investigation and documentation associated with Corrective and Preventive Action
  • Provide coaching to other functions in using problem solving structured approach, investigation tools and CAPA process
  • Collect quality data, identify key KPIs for product quality and prepare and present reports and metrics to management
  • Lead/support Annual Product Quality reviews and other periodic quality management reviews
  • Proactively lead and support Risk Management System activities, risk reduction and continuous improvement initiatives in line with company strategy
  • Perform QA review of CAPA, Change Control and Validation documentation
  • Ensure continuous resourcing and development of the PQA team
  • Ensure timely completion of all Quality System commitments
  • Ensure timely communication of GMP and or product quality issues to QA Management
  • Comply with EHS/GMP/GDP/company and corporate policies and external regulatory requirements


Qualifications

  • At least 3 years experience in Quality Assurance
  • Qualified in a Scientific or Engineering discipline (advantageous not essential)
  • Have excellent inter-personal, organisational and leadership skills
  • Be a passionate advocate of quality as a discipline and continuous improvement
  • Have experience in the use of quality improvement and problem-solving tools, and the interpretation of data
  • Completion of Six Sigma process improvement training (desirable but not essential)
  • Have experience of critical equipment and process Change Control
  • Have experience of critical equipment and process Validation
  • Uncompromising dedication to Quality
  • Personal accountability for results and integrity
  • Relentless focus on rapid and disciplined action
  • Critical thinking and problem solving
  • Strong work ethic

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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