Validation Strategist

7 days ago


Thoothukudi, Tamil Nadu, India beBeeValidation Full time ₹ 18,50,000 - ₹ 2,54,50,000

We are seeking a highly skilled Validation Lead to make a significant impact in our organization.

With a preference for minimal disruption, we are looking for someone who can develop and implement effective validation strategies from day one.

Key responsibilities include:

Validation Excellence

Develop and implement validation plans, protocols, and procedures to ensure the quality and reliability of products throughout the development lifecycle.

Collaboration & Communication

Collaborate with cross-functional teams including development, quality assurance, etc. to define validation requirements and priorities.

Regulatory Compliance & Expertise

Establish validation processes in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.

Execution, Oversight, & Risk Management

Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.

Process Improvement & Optimization

Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.

Documentation, Traceability, & Auditing

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.

Leadership, Communication, & Team Management

Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders, and raise risks proactively.

Team Development & Growth

Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.



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