Csv Analyst

**About NTT DATA**
- 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.
- This is a hands-on oversight role that will be accountable for ensuring that Client's 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
- 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
- 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 of cloud-based Computer solutions
- Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
- Project management experience for regulatory projects
- Knowledge of practices and procedures of the full software development life cycle
- Strong attention to detail
- Hands on experience with eDMS tools like Documentum or Master Control, as well as testing tools like Jira, ALM, etc.
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Strong knowledge of software development lifecycle, GAMP and CSV processes
- Working knowledge of GxP, FDA, EU and other relevant regulatory requirements for Pharma, Biotech, and med devices.
- Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSV projects
- Significant experience in authoring, reviewing and oversight of the execution of CSV documents, including Validation Plan, functional and regulatory risk assessments, User/Functional/System/Data Migration Requirements, IQ/OQ/PQ protocols, test plans, test scripts and test reports, traceability matrices as well as Validation Reports.
- Hands on experience with common tools and processes within the digital validation arena (Jira, ALM, Master Control, Documentum, First Doc, TX3, Kneat, ValGenesis, etc.)
- Understanding and experience with automated testing, including tools like Tosca and Leap Work (desirable)
- Good knowledge and experience with maintaining the validated state, including Change Management, CAPA, audits, etc.
- Strong problem-sol