AstraZeneca
Validation Associate at Fusion Pharmaceuticals
Job Description
Join Fusion Pharmaceuticals in Hamilton, ON as a Validation Associate focusing on facility and computer systems validation. Be part of redefining precision oncology in radiopharmaceuticals.
This role supports the Senior Validation Lead in ensuring compliance with regulatory requirements and internal SOPs. You will engage in developing, executing, and reviewing Computer Systems Validations and Installation, Operational, and Performance Qualification protocols. Collaboration is key as you coordinate with various stakeholders to maintain validation status and address potential risks throughout your projects.
Key Responsibilities:
• Execute and review Computer Systems Validations (CSV) appropriately
• Develop Installation, Operational, Performance Qualification (I/O/PQ) protocols
• Maintain Calibration and Preventative Maintenance schedules
• Collaborate with stakeholders on validation assessments
• Communicate project status to ensure timelines are met
Requirements...
This role supports the Senior Validation Lead in ensuring compliance with regulatory requirements and internal SOPs. You will engage in developing, executing, and reviewing Computer Systems Validations and Installation, Operational, and Performance Qualification protocols. Collaboration is key as you coordinate with various stakeholders to maintain validation status and address potential risks throughout your projects.
Key Responsibilities:
• Execute and review Computer Systems Validations (CSV) appropriately
• Develop Installation, Operational, Performance Qualification (I/O/PQ) protocols
• Maintain Calibration and Preventative Maintenance schedules
• Collaborate with stakeholders on validation assessments
• Communicate project status to ensure timelines are met
Requirements...