| Hiring Now : : SAP S4 HANA Validation Expert : : California at California, Maryland, USA |
| Email: [email protected] |
| From: Suraj Barik, Vyze Inc [email protected] Reply to: [email protected] Job Description - SAP S/4 HANA Validation Expert Location: California (Bay area) (On-Site) Duration: 12 Months MOI: Skype S4Hana experience is a MUST Candidates must be in the US and have been in the US for at least 10 years 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 Required Skills: Must have Computer system Validation experience in the Life Sciences Industry 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 Thanks & Regards Suraj barik Email: [email protected] Keywords: sfour Wisconsin Hiring Now : : SAP S4 HANA Validation Expert : : California [email protected] |
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| Thu May 16 23:20:00 UTC 2024 |