Senior Validation Specialist
1 week ago
Infosys Consulting, a global leader in next-generation digital services and consulting, seeks an experienced Senior Validation Specialist to join our team. With annual revenues of $16.31B (FY '22), we empower clients worldwide to navigate their digital transformation.
We're looking for a skilled professional to drive validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation programs. The ideal candidate will have at least 10 years of experience in the Life Sciences industry, working for a consulting services organization and/or industry experience.
Key Responsibilities:
- Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements.
- Work with clients to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations.
- Collaborate with project management to build an integrated project plan inclusive of Computer System Validation (CSV) Lifecycle Deliverables, quality gates, and summarization milestones.
- Possess knowledge of basic functions on SAP workstreams/modules and various tools/applications used in SAP implementation programs.
- Demonstrate expertise in Lean/Agile approaches to validate assets and ability to handle multiple large projects.
- Pursue and grow deep client relationships and provide leadership in critical engagements.
Requirements:
- Minimum of 10 years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
- 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.
- Knowledge of SAP Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.).
- Proven track record using Lean/Agile approaches to validate assets.
- Able to pursue and grow deep client relationships.
Where We're Hiring: Multiple Locations
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