Senior Validation Expert

1 week ago

Mount Abu, Rajasthan, India beBeevalidation Full time ₹ 14,27,520 - ₹ 25,10,400

We are seeking a highly skilled Validation Specialist to lead our validation efforts.

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  • Develop and implement comprehensive validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.
  • Collaborate with cross-functional teams, including development and quality assurance, 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, in conjunction with key stakeholders.
  • 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, validation reports, trace matrix, Change Management, Periodic reviews, and Audit Readiness.
  • Provide regular updates and reports on validation activities to Quality Assurance and senior management, and raise risks proactively.
  • Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.

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