Senior Validation Expert

2 days ago

Palakkad, Kerala, India beBeevalidation Full time ₹ 1,20,00,000 - ₹ 1,75,00,000

Our organization is looking for a seasoned professional to lead our validation efforts as Validation Lead. With a strong background in ensuring the quality and reliability of products, this individual will play a crucial role in maintaining regulatory compliance and industry best practices.

Key Responsibilities:
  • Develop and implement comprehensive validation strategies and processes throughout the development lifecycle.
  • Collaborate with cross-functional teams to define validation requirements and priorities, ensuring seamless integration with development and quality assurance.
  • Establish validation plans, protocols, and procedures in compliance with regulatory standards (FDA, ISO, MHRA) and industry benchmarks.
  • Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, guaranteeing thoroughness and accuracy.
  • Perform risk assessments and develop 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 for validation testing services as needed.
  • 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.
  • Provide regular updates and reports on validation activities to Quality Assurance, senior management, and stakeholders, proactively raising risks.
  • Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.

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