Leading Validation Expert

4 days ago

Hubli, Karnataka, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Validation Lead

 

We are seeking an experienced professional to assume the role of Validation Lead. The ideal candidate will have a strong background in validation strategies, processes, and regulatory standards.

 

Key Responsibilities:

  1. Develop and implement comprehensive validation plans, ensuring the quality and reliability of products throughout the development lifecycle.
  2. Collaborate with cross-functional teams to define validation requirements and priorities.
  3. Establish validation protocols and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) 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 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. 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.
  8. Provide regular updates and reports on validation activities to senior management and stakeholders.
  9. Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
  10. Ensure training compliance for self and project team members.

 

The successful candidate will have:

  • 6-12 years of experience in validation or a related field.
  • Strong knowledge of regulatory standards and industry best practices.
  • Excellent communication and collaboration skills.
  • Ability to lead and manage a team of validation analysts.
  • Strong problem-solving and analytical skills.
  • Experience with change management and periodic reviews.

 

As a key member of our organization, you will contribute to delivering high-quality products that meet regulatory requirements. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply with your resume and a cover letter explaining why you are the ideal candidate for this role.

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