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