Senior Validation Expert

2 days ago

Salem, Tamil Nadu, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000
Lead Validation Specialist

We are seeking a highly skilled validation specialist to join our team at Compliance Group Inc.

This is a high-priority role, and we prefer candidates with relevant experience in Validation Management.

Responsibilities
  1. Develop and Implement Validation Strategies
  • Establish and maintain validation processes and procedures that ensure product quality and reliability throughout the development lifecycle.
Collaborate with Cross-Functional Teams
  • Work with development, quality assurance, and other teams to define validation requirements and priorities.
Establish Validation Plans and Protocols
  • Develop and implement validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
Oversee Validation Activities
  • Manage the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation.
  • Review and approve test scripts based on objective evidence and ensure test adherence to testing standards.
Perform Risk Assessments
  • Conduct risk assessments and develop risk mitigation strategies to address potential product risks related to validation.
Drive Continuous Improvement
  • Implement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
Manage External Relationships
  • Manage relationships with external vendors and contractors as needed for validation testing services.
Ensure Documentation and Traceability
  • Guarantee 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
  • Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), senior management, and stakeholders.
  • Raise risks proactively and take corrective action as needed.
Lead and Manage a Team
  • Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
Ensure Training Compliance
  • Ensure training compliance of self and project team members on all customer-related training requirements.

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