Validation Specialist Job Toronto area,Ontario Canada,Healthcare

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Field Validation Specialist

Ensures current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Grifols Canada Plasma Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.

Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.

Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry

Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.

Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.

Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.

Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
Writes test cases to validate critical control points, user requirements, and functional designs. Executes test cases as needed Prepares validation reports for distribution Ensures milestones and timelines are met on assigned projects

Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
Prepares validation equipment for use at the Donor Center and for evaluation upon return. Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.

Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes

Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

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