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About the Role
Join an international team dedicated to improving healthcare and enhancing the lives of millions. Grifols is a global healthcare company with a long history of improving health and well-being worldwide, specializing in plasma-derived medicines and transfusion medicine.
Responsibilities
- Ensures adherence to current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems throughout validation protocol execution, documentation, and review.
- Travels to donor center sites to perform Operational Qualification/Performance Qualification testing.
- Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing.
- Assists in ensuring validation approaches align with current regulatory expectations and industry standards.
- Executes freezer installation, operational, and performance qualifications on-site at donor centers and affiliated locations.
- Analyzes 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 regarding Donor Center compliance and cGMP issues.
- 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 the 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.
- Tracks and monitors process/system failures/events and provides feedback to Donor Center management.
- Tracks and monitors equipment calibration due dates and failures/events and provides feedback to Donor Center management.
- Prepares donor center staff for validation activity and conducts training with donor center teams where applicable.
Requirements
- Must have experience with walk-in freezer thermal mapping.
- Experience with validation in a cGMP and/or IT environment.
Skills
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
- Excellent quantitative and analytical skills.
- Excellent oral and written communication skills.
- Strong critical thinking and problem-solving skills.
- Ability to identify errors and provide corrective action.
- Ability to work with others in a team environment.
- Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
Location
- NORTH AMERICA : Canada : ON-Toronto:CAHOME - Home Address Canada
Work Type
- On-site
- Travel up to 50% - 75%
Experience Level
- Typically requires 2 years of quality and validation experience.
Education Level
- Bachelor's degree
About the Company
- 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.