Validator

The Validator role at Three Percent involves ensuring the accuracy, reliability, and compliance of data, systems, and processes within the organization. This position requires a deep understanding of data validation techniques, quality assurance principles, and regulatory standards to maintain high data integrity across all operations. The Validator will apply thorough analytical thinking and risk assessment skills to develop validation protocols and execute comprehensive testing procedures. The role demands adherence to industry standards such as GAMP5, ICH Guidelines, and other regulatory compliance frameworks to support the organization's quality management systems and compliance objectives. The Validator is responsible for implementing and managing validation methodologies, including IQ/OQ/PQ protocol development, risk-based validation approaches, and audit trail analysis. The position focuses on maintaining compliance through meticulous documentation, validation lifecycle management, and using compliance monitoring tools. This role does not include team management but requires strong coordination with cross-functional teams to ensure all processes meet internal and external quality standards. A professional with 10 years of experience in data validation and quality assurance will be best suited for this demanding yet rewarding position.
Responsibilities

Develop, implement, and maintain validation protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) in compliance with industry standards.
Perform comprehensive data validation and verification to ensure data integrity and accuracy across various systems and processes.
Apply a risk-based approach in validation activities following GAMP5 and other relevant guidelines to prioritize actions and resources effectively.
Conduct quality assurance audits and reviews to confirm adherence to established validation methodologies and regulatory compliance requirements.
Utilize automated testing tools and audit trail review software to streamline validation workflows and improve process accuracy and efficiency.
Maintain and update documentation related to validation activities, including SOPs (Standard Operating Procedures) and validation lifecycle records.
Collaborate with regulatory and quality teams to interpret and apply compliance management software and regulatory frameworks effectively.
Identify and assess potential risks in validation processes and recommend mitigation strategies to ensure robust compliance and operational excellence.
Manage compliance monitoring activities to ensure ongoing adherence to GxP regulations, ICH guidelines, and other regulatory standards.
Evaluate and implement data validation frameworks and schemas to support system validation and quality management systems.
Coordinate with cross-functional teams to ensure all validation activities align with organizational objectives and regulatory expectations.
Stay current with industry best practices, validation methodologies, and emerging regulatory changes to continually improve validation processes.
Support audit preparations and responses through comprehensive validation documentation and evidence of compliance.
Develop and deliver training material or documentation to promote awareness of validation principles and regulatory requirements among stakeholders.