Computer System Validation Leader/Manager

About Company : . Our client is a trusted global innovator of IT and business services. They help clients transform through consulting, industry solutions, business process services, digital & IT modernization and managed services. Our client enables them, as well as society, to move confidently into the digital future. We are committed to our clients' long-term success and combine global reach with local client attention to serve them in over 50 countries around the globe. - Job Title : CSV Resource with SAP. - Location : Bangalore. - Experience : 8+ yrs. - Job Type : Contract to hire. - Notice Period : Immediate joiners. Mandatory Skills : POSITION OVERVIEW : CSV Resource POSITION GENERAL DUTIES AND TASKS : NTT Data is seeking a Computer System Validation Leader experienced in Life Sciences GxP software validation. Responsibilities : - Computer Systems Validation Leader / Manger is responsible for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance and CSV with the combination of SAP is mandatory for this position. - This is a hands-on oversight role that will be accountable for ensuring that Clients computer systems are appropriately validated before release and remain in a compliant state throughout their life. This position requires a broad range of knowledge and a deep understanding of various rules and regulations as well as international standards and guidelines. - Maintain CSV and Computer System Change Control processes. - Apply risk-based methodologies in the oversight of Computer validation and Instrument System qualification efforts. - Provide leadership and guidance to NTT Data / Client personnel on CSV matters and ensure compliance to applicable industry regulations. - Maintain CSV templates. - Conduct GxP evaluations of new Computer and Instrument Systems. - Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities. - Review CSV lifecycle documentation from a Quality perspective and approve as Quality representative. - Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner. - Review and approve System-specific Administration and User SOPs. - Oversee the readiness of the CSV program to ensure Computer Systems are compliant and ready for regulatory reviews. - Be the QA CSV Subject Matter Expert (SME) in support of audits and regulatory matters. - Provide guidance and direction throughout the GxP Computer and Instrument System Change Control process. - Ensure appropriate standards and practices are implemented for the collection, use, transfer, storage, and deletion of personal information in GxP Computer and Instrument Systems. - Perform Quality oversight and approval of periodic user access review. - Ensure CSV lifecycle documentation is completed and filed appropriately. - Maintain and present applicable metrics and key performance indicators. - Review of application vendor's qualification and/or validation documentation, as applicable. - Work with vendors for change control management, incident management and issue resolution. - Proactively identify and collate information required to assess compliance with processes and prioritize business process improvement needs. - Review, assess and update procedural documents for overall compliance with current processes, as required. - Proactively collaborate with initiative leads and senior management to develop, optimize and improve CSV processes, training, and communications. - Perform special projects, assignments, and administrative tasks per business needs. - Provide guidance and review or create varied support materials, presentations, and/or tools to support department's remit and strategies. - Mentor, coach, and support team members. Education and Experience :- 10+ years of experience working in electronic based Computer System Validation in a GxP environment. - Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process. - Experience in employing risk-based approaches to CSV. - Experience in qualification of GLP Instrument Systems. - Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems. - Experience in performing validation. (ref:hirist.tech)