Consultant - SAP S/4HANA Validation Lead (Life Sciences)
We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA, Cloud Validation, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.
Key Responsibilities
Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.
Ensure validation activities comply with regulatory and company quality requirements.
Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls
Create, review, approve, and maintain-Validation Plans (VP), User Requirements Specifications (URS), Functional & Design Specifications, Risk Assessments, IQ/OQ/PQ documents, Traceability Matrices, Validation Summary Reports (VSR) and SOPs and related quality documents
Collaborate with client Quality, Compliance, and Validation teams.
Work closely with SAP functional and technical teams across modules such as: Finance (FI/CO), Supply Chain, Manufacturing, Procurement, Quality Management and Master Data Governance (MDG)
Basic Skills & Experience
Minimum of 3+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
Experience creating, reviewing and approving / acknowledging validation deliverables.
Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security
Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
Knowledge on basic function on SAP workstreams/modules
Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.)
Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
Location: Foster City, California
Required Skills & Experience
Strong understanding of pharmaceutical compliance regulations and validation concepts.
Experience of having led large S/4 HANA transformation programs from a Validation Lead perspective
Experience with Agile and Waterfall methodologies.
Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM.
Ability to manage multiple projects and adapt to complex environments.
IT background preferred to understand program complexities.
Excellent communication and collaboration skills.
Numbers & Facts
Location
Foster City, CA
Industry
Computer/IT Services
Company Size
10,000 employees or more
Website
https://www.infosys.com/careers
About Company
Infosys is a global leader in next-generation digital services and consulting. We enable clients in 45 countries to navigate their digital transformation.
With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
Skills
Atlassian JIRAunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Cloud Computingunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Consultingunmatched
Data Migrationunmatched
Data Qualityunmatched
ERP (Enterprise Resource Planning)unmatched
Financeunmatched
GxPunmatched
Information/Data Security (InfoSec)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Master Data Management (MDM)unmatched
Multitaskingunmatched
Privacy Regulationsunmatched
Process Managementunmatched
Process Validationunmatched
Procurement Managementunmatched
Project Planningunmatched
Project/Program Managementunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Risk Analysisunmatched
Risk Managementunmatched
SAPunmatched
SAP BusinessObjects Governance Risk & Compliance (GRC)unmatched
SAP ECC (fka SAP R/3 and SAP ERP)unmatched
Sarbanes-Oxley Act (SOX)unmatched
ServiceNowunmatched
Standard Operating Procedures (SOP)unmatched
Supply Chainunmatched
System Validationunmatched
Team Playerunmatched
Technical/Engineering Designunmatched
Traceabilityunmatched
Validation Planunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.