
Highly Experienced Validation Manager
2 days ago
We are seeking a seasoned Validation Lead to spearhead validation activities across various product lines. As a key member of our team, you will be responsible for developing and implementing validation strategies to ensure the quality and reliability of products throughout the development lifecycle.
Key Responsibilities:
- Developing and Implementing Validation Strategies: Design and execute comprehensive validation plans to guarantee product quality and reliability.
- Cross-Functional Collaboration: Work closely with development, quality assurance, and other teams to define validation requirements and priorities.
- Validation Plan Development: Establish validation protocols and procedures in compliance with regulatory standards and industry best practices.
- Validation Activity Oversight: Supervise the execution of IQ/OQ/PQ, software validation, and process validation activities.
- Risk Assessment and Mitigation: Identify potential product risks related to validation and develop risk mitigation strategies.
- Continuous Improvement: Drive initiatives to enhance validation processes 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.
- Reporting and Updates: Provide regular updates and reports on validation activities to Quality Assurance, senior management, and stakeholders.
- Team Leadership: Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship.
Required Skills and Qualifications:
- Minimum 6-12 Years of Experience in validation, with a strong understanding of regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
- Excellent Leadership Skills, with the ability to collaborate effectively with cross-functional teams.
- Strong Communication Skills, with the ability to provide regular updates and reports to stakeholders.
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