- Supports initiation of new nonconformance events for the Viaflex Mixing/Filling department in the Trackwise system.
- Leads robust DMAIC Nonconformance/CAPA and complaint investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements.
- Partners with Quality and Production personnel to ensure mitigating actions are identified and implemented.
- Utilizes the Trackwise system for documentation of nonconformance/CAPA investigation results.
- Partners with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions.
- Design IQ/OQ/PQ and validation campaigns as well as develop, prepare and write the protocols for process validation, cleaning validation, IQ/OQ and performance qualification
- Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance. - Monitor and support the execution of the protocols through training, facilitating and problem solving activities
- Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control. Write protocols, manage the execution of validationtesting plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages. - Perform retrospective validation packages as required for legacy systems and processes.
- Prepare or assist in the preparation of Validation Maintenance packages.
- Provides front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
- Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols. - Remains current with respect to regulatory trends and divisional issues.
- Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.
- Partners with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs. - Support the Quality IT Systems for the department (i.e. SPC Infinity).
- Completes requested month end summary/metric reports for Management Review meeting. Support the Baxter Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created.
- Bachelor of Science, required. - ASQ Certified Quality Engineer, preferred. Major Subjects / Specialties - Science (Chemistry, Microbiology, Pharmacy, Engineering), required.
- Type of Experience Required: - Manufacturing & Quality background
- Previous experience in a GMP environment
- Knowledge of GMP, ISO and Regulatory standards
- Professional Engineer Certificate is a must Preferred:
- Knowledge of Corporate Quality requirements Years of Experience - 2 – 3 years experience in a pharmaceutical environment, required.
- 5+ years of successful experience in a pharmaceutical environment, preferred. Additional Skills / Special Training / Technical Skills Required:
- Certified Greenbelt designation.
- Strong understanding of Health Canada GMP and Medical Device Regulations.
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Strong process and project managementcapabilities. - Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization. - Ability to build strong relationships with internal and external customers. - Strong ability to balance multiple priorities.
- n/Proficiency of Minitab
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Quality Engineer - New Tecumseth, Canada - Baxter
Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
You role at Baxter
As part of the Quality Operations team, ensure Quality compliance for the assigned departments.
Support a manufacturing 3-shift operation, with requirement to support plant shutdown where applicable.
Partner with Quality and Production personnel to ensure robustcomplaint and CAPA investigations are performed and mitigating actions are identified and implemented.
Lead robust product complaint investigations and DMAIC Nonconformance/CAPA investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements.
Utilize the Trackwise system for documentation of complaint evaluation tasks and CAPA investigation results.
Support initiation of new nonconformance events for in the Trackwise system, as required.
Provide front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
Provide support for the Quality technical review/approval of department related procedural changes.
Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and ISO requirements. - Partner with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions.
Partner with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.
Support the Quality IT Systems for the department (i.e. SPC Infinity).
What you will do:
What do you bring
