Senior Validation Specialist

17 hours ago

Hubli, Karnataka, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000

We are seeking an experienced Validation Lead to fill a critical role within our organization.

About the Role:

The Validation Lead will be responsible for developing and implementing validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.

  • Develop and implement validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  • Collaborate with cross-functional teams including development, quality assurance, etc. to define validation requirements and priorities.
  • 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 along with key stakeholders like system owner and business owner.
  • 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, Audit Readiness etc.
  • Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), 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.
  • Ensure training compliance of self and project team members on all customer-related training requirements.

Requirements:

  • 6-12 years of experience in validation or a related field.
  • Strong understanding of regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  • Excellent communication and leadership skills.

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