Lead Validation Specialist

2 days ago

Ahmedabad, Gujarat, India beBeeValidation Full time ₹ 18,00,000 - ₹ 27,00,000
Lead Validation Specialist

We are seeking an experienced Lead Validation Specialist to develop and implement validation strategies and processes that ensure product quality throughout the development lifecycle.

Key Responsibilities:
  1. Validation Strategy Development: Design, develop, and implement comprehensive validation plans, protocols, and procedures to meet regulatory standards (e.g., FDA, ISO) and industry best practices.
  2. Cross-Functional Collaboration: Work closely with development, quality assurance, and other teams to define validation requirements, priorities, and timelines.
  3. Validation Activity Oversight: Ensure thorough execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, with a focus on accuracy and attention to detail.
  4. Risk Assessment and Mitigation: Identify potential product risks related to validation and develop risk mitigation strategies in collaboration with key stakeholders.
  5. Process Enhancement: Drive initiatives to enhance validation processes, streamline workflows, and increase efficiency.
  6. Vendor Management: Manage relationships with external vendors and contractors as needed for validation testing services.
  7. 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, and Audit Readiness.
  8. Team Leadership: Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.

What We Offer:

  • A dynamic and challenging work environment.
  • The opportunity to develop and implement validation strategies and processes that ensure product quality.
  • The chance to collaborate with cross-functional teams and drive process enhancements.
  • Ongoing training and development opportunities.
  • A competitive compensation package.

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