Hi, Please send Profiles to *na...@canopyone.com*
*Title : Validation Lead* *Location : Chicago,IL* *Duration : 12 months* * JOB DESCRIPTION* The Infrastructure Qualification/Validation Lead will drive the qualification requirements and execution of multiple hardware/infrastructure prioritized efforts accross Global IT. * Purpose of the Position: * 1. Function as Qualification / Validation Lead on multiple assigned infrastructure projects for hardware refreshes, upgrades, and/or modifications to infrastructure needed to support quality systems and applications. Projects may include virtualization, physical moves, and datacenter quaifications. as well as span global locations. * Critical Job Responsibilities: * 1. As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity. 2. Participate in and guide team in generating/modification Design Specifications. 3. Gain understanding and follow defined SDLC. Ensure quality validation processes are executed as defined by procedures. 4. Develop strategy for the qualifcation aspects of the project, using risk-based approach to determine testing, documentation and verification activities, with appropriate justification of the approach. 5. Deploy strategy and documentation requirements. 6. Manage electronic routing of required documentation-ensuring compliance to current procedure for e-approval. 7. Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project. 8. Manage qualification testing -coordinating documentation and testing activities. Generate test scripts, as needed. Execute testing as required. 9. Collaborate with vender(s), quality, and technical individuals throughout project in generation of project / qualification required deliverables. 10. Prepare qualification package for archival. * Required Qualifications: * 1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business. 2. Highly skilled in Computerized System testing and validation in the healthcare industry. At least 7-10 years validation experience in both infrastructure qualification. 3. Proven results in managing qualification aspects of infrastructure project implementation. 4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211, 820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations. 5. Experience with use/control of Electronic Records/Electronic Signatures and document management systems, as well as Quality Center--HPQC for testing. 6. Strong technical background-preferably with document management systems. 7. Experience working in a highly regulated environment; GxP, QSR framework preferred. 8. Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills. 9. Excellent communication including written, verbal, and listening skills. 10. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision. -- You received this message because you are subscribed to the Google Groups "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/groups/opt_out.
