Job Description | Infosys is seeking candidates who have demonstrated experience with validation of ERP applications such as SAP ECC and SAP S/4 HANA. The identified candidate will support a large S/4 HANA transformation program from a validation SME perspective. Below are the role expectations: - Minimum of 12+ 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
- 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 and recommend for risk-based testing approach as required.
- Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary.
- 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.)
- Successful track record using Lean/Agile approaches to validate assets
- Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
- Ability to pursue and grow deep client relationships
- Provide leadership in critical engagements and drive successful outcomes
- Preferable IT background to understand larger impact of architecture / technical complexities on the program
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