| Validation Engineer from Foster City, CA || Raleigh, NC only (ONSITE) at Raleigh, North Carolina, USA |
| Email: [email protected] |
| From: Ayush Sharma, HMG America [email protected] Reply to: [email protected] HMG America LLC is the best Business Solutions focused Information Technology Company with IT consulting and services, software and web development, staff augmentation and other professional services. One of our direct clients is looking for Validation Engineer with GXP in Raleigh , NC . Below is the detailed job description. Title: Validation Engineer with GXP Location: Raleigh , NC Onsite from Day-1 Duration: 6 months Job Description: This position is for Validation lead with experience in validating SAP system. The candidate may or may not have SAP technical skills as functional consultant or technical consultant but should understand the SAP ERP landscape and the validation approach. This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system 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 Review the test scripts for the requirements and test scenario coverage Lead overall protocol executions, log and track defects Review the executed test reports 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 Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics. Maintain overall project and issue tracker and report routinely 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 Maintain day to day activities status tracker and report routinely Lead the team of validation engineers located in different time zones 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 Excellent knowledge of computer system validation and GAMP -5 standards Team management. Keywords: sfour information technology North Carolina Wisconsin |
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| Sat Jan 21 04:30:00 UTC 2023 |