Senior Validation Leader

3 days ago

Surat, Gujarat, India beBeeRegulatory Full time ₹ 12,49,600 - ₹ 18,17,900
Validation Strategist

Compliance Group Inc. is seeking a highly skilled Validation Strategist to lead our validation efforts.

Key Responsibilities:
  • Develop and implement thorough validation strategies, processes to ensure quality and reliability of products throughout the development lifecycle.
  • Collaborate with cross-functional teams including development, assurance, etc. to define validation requirements and priorities.
  • Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  • Oversee execution of validation activities, ensuring thoroughness and accuracy, including IQ/OQ/PQ, software validation, process validation.
  • Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation along with key stakeholders.
  • Drive continuous improvement initiatives to enhance validation processes, streamline workflows, increase efficiency.
  • Manage relationships with external vendors and contractors as needed for validation testing services.
  • Ensure end-to-end documentation and traceability of validation activities, including validation plans, test plans, test protocols, test reports, validation reports, trace matrix.
  • Provide regular updates and reports on validation activities to Quality Assurance, status to senior management and stakeholders, raise risks proactively.

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