
Senior Validation Specialist
17 hours ago
We are seeking a highly skilled professional to lead our validation efforts.
Key Responsibilities:- Develop and implement effective validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.
- Collaborate with cross-functional teams to define validation requirements and priorities.
- Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g. FDA, ISO) and industry best practices.
- Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
- Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
- Manage relationships with external vendors and contractors as needed for validation testing services.
- Ensure end-to-end documentation and traceability of validation activities, including validation plans, test plans, test protocols, test reports, and validation reports.
- Provide regular updates and reports on validation activities to senior management and stakeholders.
The ideal candidate will have 6-12 years of experience in validation and excellent leadership skills.
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