The Computerised System Validation (CSV) Specialist is responsible for ensuring that computerised systems used in regulated environments comply with applicable GxP regulations and remain in a validated state throughout their lifecycle.The role focuses on system validation aligned with international regulatory guidelines such as the FDA, European Medicines Agency, ISPE, and GAMP (GAMP 5).Specific Responsibilities:Validation Strategy:Develop and implement a validation strategy for electronic systems, ensuring compliance with industry regulations and company standards.This includes defining validation requirements, protocols, and procedures.Test Planning and Execution:Create and execute test plans and protocols to validate electronic systems, including software applications, enterprise IT applications, databases, and infrastructure.Conduct functional, performance, and security testing to ensure system reliability and data integrity.Documentation and Compliance:Prepare and maintain validation documentation, including validation plans, test scripts, and validation reports.Ensure compliance with regulatory requirements, such as Good Practices (GxP) and other relevant guidelines.Risk Assessment and Mitigation:Identify potential risks associated with electronic systems and develop risk mitigation strategies.Conduct risk assessments, implement risk controls, and monitor ongoing compliance to minimize the impact of risks on pharmaceutical warehousing operations.Change Control and Continuous Improvement:Manage the change control process for electronic systems, assessing the impact of changes on quality and compliance.Implement continuous improvement initiatives to enhance the validation process, streamline procedures, and adopt emerging technologies.Requirements and Personal Skills:Knowledge of Pharma Industry and Quality Assurance:A strong understanding of the pharmaceutical industry, its regulatory environment, and quality assurance processes is crucial.Familiarity with phar