Senior Validation Professional

1 day ago

Tiruppur, Tamil Nadu, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Validation Lead

We are seeking an experienced professional to oversee the development and implementation of validation strategies and processes, ensuring quality and reliability across the product lifecycle.

This role requires collaboration with cross-functional teams, establishing validation plans, protocols, and procedures in line with regulatory standards and industry best practices.

Key Responsibilities:
  • Develop and implement robust validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.
  • Collaborate with development, quality assurance, and other cross-functional teams to define validation requirements and priorities.
  • Establish comprehensive validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  • Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
  • Perform risk assessments and develop mitigation strategies to address potential product risks related to validation.
  • Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and 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, change management, periodic reviews, audit readiness, etc.
  • Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), senior management, and stakeholders, and raise risks proactively.
  • Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
  • Ensure training compliance of self and project team members on all customer-related training requirements.
Requirements:

The ideal candidate will have 6-12 years of experience in validation, preferably in the pharmaceutical or medical device industry. A degree in a relevant field is required, along with excellent communication and leadership skills.

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