Please share resume for the below position at jyot...@usgrpinc.com
*Position:: SAP FDA QA Lead* *Location:: Scottsdale , AZ* *Duration:: 6+ months* *Rate:: $55/hr on C2C (Fix)* *Note:- VISA copy required for submission.* *Mandatory Technical / Functional Skills :-* · At least 3 years’ experience with software systems validation and testing. Requires thorough understanding of System Development Life Cycles for FDA regulated applications. · Excellent understanding of test execution and typical defect management practices in an FDA-regulated environment. · Experienced with high volume application testing environment. Requires thorough knowledge of US CFR 21 Part 11 regulations. Requires working knowledge of at least one of the following: US CFR 200 or 300 or 800 series. Experience of HP Quality Center's Test Plan, Test Lab and Defect modules is required. · Knowledge of SAP ERP for FIN, OTC, RTP, FTS and Logistics processes is a plus. · Experience with automated Software Testing tools is a plus. Familiarity with QA Systems is a plus. *Roles and responsibility :-* · Act as a liaison between the compliance team, project team, and key stakeholders for major SAP project. · Create and perform review and approval of documentation deliverables. · Enforce validation and quality requirements and Good Documentation Practices for validation documentation. · Manage the routing and approval of system documentation through document management system. · Must be comfortable in a leadership role. · Must be flexible to meet aggressive deadlines. · Partner with project team to communicate and understand compliance requirements. · Report to the Compliance and Validation Lead, and provide status updates. *Desirable Technical / Functional Skills :-* · Experienced in working within an FDA regulated environment for the Pharmaceutical and/or Medical Device industries. · Ability to work within a Project Team setting. · Ability to guide a project team through the validation process. · Track, schedule and manage validation issues to ensure commitment dates are met. · Jointly develop, communicates plan with project team. · Insure timely flow of information with project team. *Thanks and regards,* *Jyoti Budhwar* United Software Group Inc. 565 Metro Place S. Suite # 110 Dublin, OH 43017 Phone: 614-588-8586 Fax: 1-866-764-1148 Email : Gtalk : Jyotibudhwar26 *http://www.usgrpinc.com <http://www.usgrpinc.com/>* -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to international-sap-projects+unsubscr...@googlegroups.com. To post to this group, send email to international-sap-projects@googlegroups.com. Visit this group at https://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
