Validation Professional

3 days ago

Vellore, Tamil Nadu, India beBeeValidator Full time ₹ 15,00,000 - ₹ 21,50,000
Job Opportunity

We are seeking an experienced validation professional to join our organization.

This role requires a strong understanding of validation strategies, processes, and regulatory standards.

Key Responsibilities
  1. Develop and implement comprehensive validation plans and protocols to ensure product quality and reliability throughout the development lifecycle.
  2. Collaborate with cross-functional teams to define validation requirements and priorities, ensuring alignment with industry best practices and regulatory standards.
  3. Establish and maintain validation procedures, protocols, and records in compliance with FDA, ISO, MHRA regulations and industry standards.
  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 mitigation strategies to address potential product risks related to validation.
  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, and validation reports.
  9. Provide regular updates and reports on validation activities to senior management and stakeholders.
Requirements
  • 6-12 years of experience in validation, preferably in the pharmaceutical or medical device industry.
  • Strong knowledge of validation strategies, processes, and regulatory standards (FDA, ISO, MHRA).
  • Ability to collaborate effectively with cross-functional teams and communicate complex information to various stakeholders.
  • Experience in managing validation activities, including IQ/OQ/PQ, software validation, and process validation.
  • Excellent problem-solving skills, with the ability to analyze complex problems and develop effective solutions.
  • Strong leadership and interpersonal skills, with the ability to lead and motivate a team.

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