| S4 Validation Expert at Remote, Remote, USA |
| Email: [email protected] |
| S4 Validation Expert Location: California (Bay area) Duration : 1 year JD - Expertise : Validation Expert for S4Hana, (S4Hana experience is a MUST) Please note: S4Hana experience is a MUST Job Requirements: Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation plan Develop functional risk strategy and perform functional risk assessment Review user business process documents and user requirements specification Review functional, technical and configuration design documents Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios Support overall protocol executions, log and track defects Review the executed test protocols for the proper documentation of test results and evidence Review the defects for proper documentation per the checklist Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested Prepare and approve qualification summary report Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials Skills: Excellent communication (oral and written) and attention to detail 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11 (MUST HAVE) Excellent knowledge of computer system validation and GAMP -5 standards -- Piyush Vashney Senior Technical Recruiter, VYZE INC +1 703 982 7189 | +91 8533070615 | vyzeinc.com [email protected] 24718 Tribe Square #306, Dulles VA 20166 Disclaimer: This communication, along with any documents, files or attachments, is intended only for the use of the addressee and may contain confidential information. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of any information contained in or attached to this communication is strictly prohibited, To remove your email address permanently from future mailings, please send RMOVE to [email protected] -- Keywords: sfour sfour information technology Virginia Wisconsin S4 Validation Expert [email protected] |
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| Mon Aug 05 23:39:00 UTC 2024 |