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.
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
Domain (Industry): Life Sciences & Pharma
Total Experience (Ex. 5-7 Years): 10+ years
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