Senior Validation Strategist
3 days ago
We are seeking a highly skilled Senior Validation Strategist to develop and implement validation strategies, ensuring the quality and reliability of products throughout the development lifecycle.
About the Role:
The Sr. Validation Strategist will be responsible for developing validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
- Validation Strategy Development: Develop comprehensive validation strategies that meet regulatory requirements and industry best practices.
- Cross-Functional Collaboration: Collaborate with cross-functional teams to define validation requirements and priorities.
- Validation Execution: Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation.
- Risk Management: Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Process Improvement: Drive continuous improvement initiatives to enhance validation processes and streamline workflows.
- Team Leadership: Lead and manage a team of validation analysts, providing guidance and mentorship to ensure their professional growth and development.
- Compliance: Ensure training compliance of self and project team members on customer-related training requirements.
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