Validation Lead

4 weeks ago

Hyderabad, Telangana, India Compliance Group Inc Full time
We are looking for Validation Lead

Experience : 6 to 12 years

Location: Hyderabad (Remote)

1. Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.
2. Collaborate with cross-functional teams including development, quality assurance, etc. to define validation requirements and priorities.
3. Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
4. Oversee the execution of validation activities, including 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.
5. Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation along with key stakeholders like system owner and business owner.
6. Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
7. Manage relationships with external vendors and contractors as needed for validation testing services.
8. 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.
9. Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders and raise risks proactively.
10. Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
11. Ensure training compliance of self and project team members on all customer related training requirements.

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