Lead Validation Specialist

1 day ago

Gandhinagar, Gujarat, India beBeeValidation Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Lead Validation Specialist

We are seeking an accomplished Lead Validation Specialist to drive quality and reliability in product development.

  • Develop Comprehensive Validation Strategies: Create detailed plans, protocols, and procedures to ensure product quality and reliability throughout the development lifecycle.
  • Collaborate with Cross-Functional Teams: Work closely 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: Execute IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy. Review and approve test scripts based on objective evidence and ensure test adherence is followed as per testing standards.
  • Perform Risk Assessments: Identify potential product risks related to validation and develop risk mitigation strategies in collaboration with key stakeholders like system owner and business owner.
  • Drive Continuous Improvement: Enhance validation processes, streamline workflows, and increase efficiency through continuous improvement initiatives.
  • Manage External Vendors: Manage relationships with external vendors and contractors for validation testing services as needed.
  • Maintain 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.
  • Provide Regular Updates: Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders, and raise risks proactively.
  • 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.
  • Educate and Train Team Members: Ensure training compliance of self and project team members on all customer-related training requirements.

This is a pivotal role that requires strong leadership skills, attention to detail, and ability to work effectively in a team environment. The ideal candidate should have 6-12 years of experience in developing and implementing validation strategies, collaborating with cross-functional teams, and ensuring regulatory compliance.

Responsibilities:

  • Develop and implement comprehensive validation strategies
  • Collaborate with cross-functional teams to define validation requirements and priorities
  • Establish validation plans and protocols in compliance with regulatory standards and industry best practices
  • Oversee validation activities, ensuring thoroughness and accuracy
  • Perform risk assessments and develop risk mitigation strategies
  • Drive continuous improvement initiatives to enhance validation processes and increase efficiency
  • Manage relationships with external vendors and contractors for validation testing services
  • Maintain end-to-end documentation and traceability of validation activities
  • Provide regular updates and reports on validation activities to Quality Assurance and senior management
  • Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship
  • Educate and train team members on customer-related training requirements

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