Product Validation Expert

3 days ago

Thrissur, Kerala, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Validation Lead Job Description

We are seeking a skilled Validation Lead to fill this role at our organization with a preference for a short notice period.

Key requirements include:

  1. Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.
  2. Collaborate with cross-functional teams, including development, quality assurance, to define validation requirements and priorities.
  3. Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO) and industry best practices.
  4. Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
  5. Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation, working with stakeholders like system owners and business owners.
  6. Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
  7. Manage relationships with external vendors and contractors as needed for validation testing services.
  8. Ensure end-to-end documentation and traceability of validation activities, including validation plans, test plans, test protocols, test reports, validation reports, and change management.
  9. Provide regular updates and reports on validation activities to quality assurance, senior management, and stakeholders, raising risks proactively.
  10. Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to support their professional growth and development.
  11. Ensure training compliance for self and project team members on customer-related training requirements.

This role is ideal for individuals who have experience in developing and implementing validation strategies and processes, collaborating with cross-functional teams, establishing validation plans, protocols, and procedures, overseeing validation activities, performing risk assessments, driving continuous improvement initiatives, managing relationships with external vendors and contractors, ensuring end-to-end documentation and traceability of validation activities, providing regular updates and reports, leading and managing a team of validation analysts, and ensuring training compliance.

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