
Senior Validation Professional
1 week ago
We are seeking a highly experienced professional to join our team as a Validation Lead.
About the Role- Develop and implement validation strategies and processes to ensure the quality and reliability of products 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, MHRA) 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 for validation testing services.
- Ensure end-to-end documentation and traceability of validation activities, including validation plans, test plans, test protocols, test reports, validation reports, trace matrix, change management, periodic reviews, audit readiness etc.
- Provide regular updates and reports on validation activities to Quality Assurance, status to senior management and stakeholders, and raise risks proactively.
- Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
Kindly apply only if you have relevant experience or share this opportunity with a friend or colleague seeking a change.
Key Responsibilities:
- Product Validation Specialist: Develop and execute validation strategies to ensure product quality and reliability.
- Process Improvement Expert: Drive continuous improvement initiatives to enhance validation processes and increase efficiency.
- Risk Management Specialist: Perform risk assessments and develop risk mitigation strategies to address potential product risks.
- Team Lead: Lead and manage a team of validation analysts, providing guidance and mentorship.
This role requires strong analytical, problem-solving, and communication skills. If you have a background in quality assurance, regulatory affairs, or a related field, we encourage you to apply.
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