Product Validation Manager

6 days ago

Rajahmundry, Andhra Pradesh, India beBeeValidation Full time ₹ 1,60,00,000 - ₹ 2,01,00,000
Job Summary

We are seeking a highly experienced and skilled professional to lead the development and implementation of validation strategies and processes.

This is a challenging role that requires the ability to develop and implement effective validation plans, collaborate with cross-functional teams, and oversee the execution of validation activities.

Key Responsibilities:
  1. Validation Strategy Development: Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.
  2. Cross-Functional Collaboration: Collaborate with cross-functional teams including development, quality assurance, etc. to define validation requirements and priorities.
  3. Validation Planning: Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  4. Validation Execution: Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
  5. Risk Assessment: 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.
  6. Continuous Improvement: Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
  7. Vendor Management: Manage relationships with external vendors and contractors as needed for validation testing services.
  8. Documentation and Traceability: 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.
  9. Reporting and Communication: Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders, and raise risks proactively.
  10. Team Leadership: Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
Requirements:
  • 6-12 years of experience in a relevant field.
  • Proven track record of developing and implementing effective validation strategies and processes.
  • Excellent communication and collaboration skills.
  • Ability to lead and manage a team of validation analysts.
  • Strong analytical and problem-solving skills.

We encourage you to apply if you have relevant experience or share this opportunity with someone who might be interested.

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