Hello, Greetings from Clifyx.

• Visa Independent
• Job Title
• Validation SME [IT CSV for SAP Application]

Location:

Hybrid ( mandatory 3 days work from client s office in Foster City, California ) 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 Relevant Experienc 10+ years Mandatory skills

• Strong communication and presentation skills Validation of SAP systems Desired skills
• Good stakeholder management skills Domain (Industry)
• Life Sciences & Pharma Total Experience (Ex. 5-7 Years)
• 10+ years Thanks & Best Regards, Vishal Swami
• Clifyx (US IT Recruiter) Contact Number

•

LinkedIn:

Headquarters:

South Plainfield, NJ

• 07080