Process and Compliance Support

Req ID:

We are currently seeking a Process and Compliance Support to join our team in Bangalore, Karnātaka (IN-KA), India (IN).

Responsibilities

• Accountable for the timely readiness of Data Migration compliance aspects and components for each deployment. This includes project management activities in SolMan, DVS, and DMW readiness, Test Plans and Tester readiness, and readiness of Veeva (security scope etc.).
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• Responsible for monitoring the evolution of the migration platform and components, along with planning and ensuring compliant platform and processes. Works with the NTT DATA global Quality and Regulatory Assurance leadership to leverage best practices and develop a process that will keep this data migration-as-a-service program compliant at all times.
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• Drives adherence to the established Data Migration Strategy and processes, and architecture principles and technology standards.
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• Implements a Risk Assessment and Management process and ensures that guidelines are followed in execution.
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• Collaborates with all internal and external auditors, and audit coordination groups, in closely aligning Data Migration teams with respective audit planning and delivery support.
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• Audits deployment activities as per the Data Migration Strategy in alignment with the CSV Teams and deployments.
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• Represents Data Migration services in internal and external audits.
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• Responsible for training and preparing Data Migration teams for their involvement in, and support of, audits.
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• Performs audits on authorization to S/4, eWM, and SAP DS/IS with DM roles.
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• Ensures SAP DS/IS as a platform is following client Information Security standards and expectations.
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Key Skills

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• 10+ years of compliance experience CSV, GMP, GAMP 5, V-Model, CAPA, SOPs, Internal and External Audits
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• Solid knowledge of legal impact topics, such as FDA regulations and EU Regulations 21 CFR Part 11 & Annex 11 - EU Annex 11
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• Several years of experience in Life Science software implementation programs/projects including IQ, OQ, PQ
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• Several years of project management and Quality Assurance experience
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• Hands-on experience in monitoring and assessing systems to ensure they comply with industry and security standards, as well as corporate and regulatory policies and requirements.
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• Leadership experience in risk assessment, standards and controls, training and communication, and oversight.
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• Experience in Data Migration, specifically for S/4 HANA.
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• Solid User experience with SAP SolMan and MS Office and Google Office applications
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• Experience and technical knowledge of Data Migration tools; mainly SAP BODS Business Objects Data Services, SAP migration cockpit Tools and Methodology.
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• Experience with use of AGILE tools – Jira.
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• Motivated self-starter with exceptional interpersonal communication and presentation skills along with the ability to lead and influence others.
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• Strong organizational, decision-making, and issue/conflict resolution skills.
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• Proven track record of working with diverse, cross-functional teams that are located regionally and worldwide.
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• Excellent client-facing and internal communication skills with ability to build strong relationships with senior stakeholders within IT and Businesses stakeholders.
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• Ability to communicate (oral/written) effectively in English to exchange information with our client.
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Desirable Skills (nice to have)

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• Prior experience in Pharmaceutical and/or Healthcare industries.
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• Familiarity with onsite-offshore models and has led a team of offshore and onsite developers.
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• Understanding of compliance requirements for Life Sciences industry (i.e., GxP, CSV).
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About NTT DATA Services:

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NTT DATA Services partners with clients to navigate and simplify the modern complexities of business and technology, delivering the insights, solutions and outcomes that matter most. We deliver tangible business results by combining deep industry expertise with applied innovations in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure, and business process services.

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NTT DATA Services, headquartered in Plano, Texas, is a division of NTT DATA Corporation, a top 10 global business and IT services provider with 100,000+ professionals in more than 50 countries, and NTT Group, a partner to 85 percent of the Fortune 100. Visit nttdataservices.com to learn more.

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About NTT DATA

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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.