CSV - Validation Lead

Job Responsibilities To create, assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. To ensure process improvement and compliance in the assigned module and participate in technical discussions/review. To create work plans, monitor and track the work schedule for on time delivery as per the defined quality standards. To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. To develop and guide the team members in enhancing their technical capabilities and increasing productivity. Mandatory Skills CSV for SAP systems/projects Additional Requirements Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements. Proficiency in validating SAP systems and associated healthcare applications, including creating and executing validation plans, protocols, and reports (IQ, OQ, PQ). In-depth knowledge of healthcare regulatory compliance, including HIPAA and other industry standards, to ensure validated systems meet operational and legal requirements. Experience in risk-based validation approaches, focusing on critical system functionalities and maintaining compliance while optimizing validation efforts. Strong understanding of SAP healthcare modules (e.g., MM, SD, FICO, EHS) and their integration with other systems to design effective validation strategies. Excellent problem-solving skills to identify, document, and resolve validation issues, ensuring systems operate reliably and meet compliance standards. Effective communication and collaboration skills to work with cross-functional teams, including quality assurance, IT, and business stakeholders, to ensure successful validation processes. Develop and execute comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports to ensure SAP systems and associated healthcare applications meet regulatory and operational requirements. Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA, by validating system functionalities and documentation processes. Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based validation strategies. Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results, ensuring systems function as intended in a healthcare environment. Identify and resolve validation issues, conducting root cause analyses and implementing corrective actions to maintain compliance and system reliability. Provide training and guidance on CSV processes to stakeholders, ensuring understanding and adherence to validation standards and best practices. Stay updated on healthcare regulations and validation trends, advising on improvements to validation strategies and ensuring the organization's systems remain compliant and efficient. #J-18808-Ljbffr TechDigital Group