CSV

Develop and maintain computer system validation (CSV) policies, procedures, and documentation in alignment with regulatory requirements (e.g., FDA, EMA, GxP), industry standards (e.g., GAMP), and company quality management systems

Lead and manage the execution of CSV projects, including risk assessments, validation planning, requirements gathering, testing, documentation, and validation reporting for computerized systems and software applications

Collaborate with cross-functional teams, including IT, quality assurance, regulatory affairs, and business stakeholders, to ensure that computer systems and software applications meet user requirements, functional specifications, and compliance standards

Conduct validation assessments and gap analyses for new or existing computer systems to identify validation gaps, risks, and opportunities for improvement, and develop remediation plans as needed

Review and approve validation documentation, including validation plans, protocols, test scripts, traceability matrices, and validation reports, to ensure completeness, accuracy, and compliance with regulatory expectations

Provide CSV guidance, training, and support to project teams, system owners, and validation professionals on validation principles, best practices, and regulatory expectations

Stay informed about emerging trends, regulatory changes, and industry developments related to CSV, computerized systems, data integrity, and electronic records management, and recommend proactive measures to address evolving requirements

Participate in regulatory inspections, audits, and assessments related to computer system validation, providing documentation, evidence, and support as needed to demonstrate compliance with regulatory requirements