SAP CSA Lead

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We are currently seeking a SAP CSA Lead to join our team in Bangalore, Karnātaka (IN-KA), India (IN).

SAP CSA Lead

NTT Data is seeking a Computer Software Assurance (CSA) Lead experienced in Life Sciences SAP implementation validation to join our dynamic and growing Quality and Regulatory Assurance (QRA) team.

Responsibilities

• Operate as a key member of large SAP application upgrades and installation projects representing the Quality and Regulatory Assurance (QRA) department in all project meetings and discussions.
• Provide validation road map and best practices for SAP S4HANA Green and brown field implementations.
• Work as a validation consultant for the client, taking the lead in all responsible meetings, capturing key notes, minutes of meetings, sharing the agenda in advance, and providing status reports.
• Author, and manage the review and approval of key project deliverables including the Validation Plan, URS, FRS, CS/TS, DS, Cutover, IQ/OQ/PQ, Traceability Matrix, Test Plans, and Reports, Validation Report in client or NTT eDMS or VLMS.
• Provide GxP validation expertise to enable the project team to adapt to changes and issues and make quick decisions.
• Work with stakeholders, business representatives, and counterparts to coordinate and ensure on-time delivery of all CSA/CSV deliverables, including documenting requirements, qualifications and user acceptance test scripts that adequately ensure business requirements are met for a given system.
• Participate in all SDLC activities for the project and maintain relevant documentation.
• Ensure that GxP applications maintain their validated state during the system lifecycle.
• Provide system audit support and ensure inspection readiness of applications.
• Work with QA, Computer Validation Committee, and IT to document CAPAs, audit observations, and other quality items.
• Review of application vendor's qualification and/or validation documentation, as applicable.
• As necessary, 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.
• Maintain, review, assess and update QMS related documents and other 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.
• Maintain entities, project, release, training, testing and administrative documentation in Kneat and/or client specific VLMS or EDMS systems.
• Provide guidance and review or create varied support materials, presentations, and/or tools to support departments remits and strategies.
• Mentor, coach, and support team members on GxP and QMS aspects.

Education and Experience

• 6+ years of experience working in electronic based Computer System Validation in a GxP environment, including at least 2 years of SAP S4 HANA validation experience.
• Experience working with SAP Quality Management, Manufacturing, Warehouse, Material, and Procurement modules.
• Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
• Knowledge of practices and procedures of the full software development life cycle.
• Strong attention to detail.
• Hands on experience with VLMS tools like ALM, Kneat and ValGenesis, and Veeva eDMS tools like Documentum or Master Control, as well as testing tools like Jira, , 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).
• GAMP5, 21CFR, EU11, Data Integrity, ICHQ9, Saas/ Cloud, GxP and VLMS/eDMS application training (desirable).

Desirable Knowledge, Skills, and Abilities

• Strong regulatory knowledge in 21CFR, EMA, PIC(S), ICH, GAMP 5 v2 and CSA and CSV processes.
• Strong working knowledge of SAP S4 HANA, its modules and how they are used within Life Sciences companies.
• Working knowledge of GxP, FDA, EU and other relevant regulatory requirements for Pharma, Biotech, and med devices.
• Understands electronic signature, vendor qualification, quality agreements, SLA, SOW. Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSA/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 (Kneat, ValGenesis, SAP Cloud ALM, Jira, ALM, Master Control, Documentum, First Doc, TX3, etc.).
• Understanding and experience with automated testing, including tools like Tosca and Leap Work (optional).
• Good knowledge and experience with maintaining the validated state, including Quality Management, Change Management, periodic review, CAPA, audits, etc.
• Strong problem-solving, verbal, written, and presentation skills.
• Proficiency in Microsoft Office 365, cloud tools, VPN, Citrix, and other productive tools.
• Able to manage projects as project manager, maintaining project plan and prioritize a variety of tasks and meet strict deadlines with limited to no supervision.
• Ability to maintain a positive and professional demeanor.
• Ability to work effectively within a team to attain a shared goal.
• Able to make critical decisions and take ownership and accountability.

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client's needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, .

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