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2 days ago
We are seeking a highly experienced Validation Specialist to join our organization at the Compliance Department.
The ideal candidate will have a strong background in developing and implementing validation strategies and processes, ensuring product quality throughout the development lifecycle.
- Develop Validation Strategies: Create and implement validation plans, protocols, and procedures that meet regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
- Collaborate with Cross-Functional Teams: Work closely with development, quality assurance, and other teams to define validation requirements and priorities.
- Execute Validation Activities: Oversee IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy. Review and approve test scripts based on objective evidence.
- Risk Assessment and Mitigation: Perform risk assessments and develop strategies to address potential product risks related to validation.
- Continuous Improvement: Drive initiatives to enhance validation processes, streamline workflows, and increase efficiency.
- Vendor Management: Manage relationships with external vendors and contractors as needed for validation testing services.
- Documentation and Traceability: Ensure end-to-end documentation and traceability of validation activities.
- Team Leadership: Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship.
As a key member of our team, you will be responsible for ensuring the highest level of product quality and reliability. You will work closely with cross-functional teams to ensure validation requirements are met and priorities are defined. Additionally, you will oversee validation activities, perform risk assessments, and drive continuous improvement initiatives.
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