
Senior Validator
5 days ago
We are seeking a highly experienced professional to lead our validation efforts at Compliance Group Inc.
The ideal candidate will have a minimum of 6-12 years of experience in validation and a strong background in developing and implementing validation strategies and processes.
The role requires collaboration with cross-functional teams, including development, quality assurance, etc. to define validation requirements and priorities.
- Develop and Implement Validation Strategies: Create and implement comprehensive validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO) and industry best practices.
- Collaborate with Cross-Functional Teams: Work closely with development, quality assurance, and other teams to define validation requirements and priorities.
- Establish Validation Plans and Protocols: Develop and establish validation plans, protocols, and procedures that ensure the quality and reliability of products throughout the development lifecycle.
- Oversee Validation Activities: Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
- Risk Assessment and Mitigation: Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
- Continuous Improvement Initiatives: Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
- Team Management: Manage relationships with external vendors and contractors as needed for validation testing services and lead a team of validation analysts, providing guidance, coaching, and mentorship.
Responsibilities include ensuring end-to-end documentation and traceability of validation activities, providing regular updates and reports on validation activities, and ensuring training compliance of self and project team members.
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