Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Field Validation Specialist role.
Rezi rewrites your resume against GRIFOLS, S.A.'s job description. Free.
Tailor your resume to this Field Validation Specialist role.
Rezi rewrites your resume against GRIFOLS, S.A.'s job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Field Validation Specialist posting at GRIFOLS, S.A. — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Field Validation Specialist posting at GRIFOLS, S.A. — free, in seconds.
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 developing, producing, and marketing innovative medicines, solutions, and services worldwide.
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 for timely approval before routine use.
- 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 confirm 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 for 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 for revalidating processes, systems, and equipment, including evaluating new methodologies and resolving performance issues.
- 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 as applicable.
Requirements
- Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
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.
- Knowledge of 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
- 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.
- We develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Equal Opportunity
- Canada Careers Privacy Notice
- Politique de confidentialité de Canada - Careers