Validation Lead
10 hours ago
We are looking for Validation Lead for Compliance Group Inc. High preference to short notice period.
Experience : 6 to 12 years
Location: Hyderabad (Remote)
- Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.
- Collaborate with cross-functional teams including development, quality 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 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.
- 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.
- 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), status to 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.
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