*Dear Friends,* *Please send me suitable profiles to [email protected]. **SendResumes in word format with contact number,current location and billing rate.*
* Position: **VALIDATION LEAD QTS* *Location: - Vernon Hills IL loca to **Chicago** or Vernon Hills, Illinois* *Duration: - 8 Months* *Rate: $45**/ hr.* *Interview: - Phone and face to face* *Resumes needed: - only one who matches 100%* *Quality Compliance Validation Lead * *Job Skills Template* *Purpose of the Position*: *Act as Validation Lead in the Quality Compliance organization for the Quality Tracking System (QTS/Trackwise) project. The scope of this project is the addition of two workflows—Audit and FCA—to the existing system. * *Critical Job Responsibilities*: 1. *Generate / revise Validation Master Plans, Qualification Protocols, Test Plans, Risk Assessments, and Reports, as needed. May participate in generating User Requirements, Functional and Design Specifications. * 2. *Gain understanding and follow defined Software Development Life Cycle and company procedures. Ensure quality validation processes are executed as defined by processes and procedures. * 3. *Participate in design meetings, as required, to gain knowledge of project, system, customizations configuration to succeed at delivering assigned project deliverables. * 4. *Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project. * 5. *Train testers on qualification process and incident reporting. * 6. *Manage validation schedule. Coordinate and assign testing to a team of testers. Generate test scripts, as needed. Execute testing as required. * 7. *Post-execution review of test cases for completeness, accuracy and adherence to policies and procedures. * 8. *Assist in creation of and review/approval of Trace Matrix. * 9. *Overall document management for all validation deliverables including, but not limited to: managing all aspects of validation package contents; assisting in the routing/approval process of documents; archiving documents. * 10. *Collaborate with business, quality, and technical individuals throughout project in generation of project / validation required deliverables. * *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. Prefer at least 7 years validation experience in application validation. * 3. *Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211, 820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations. * 4. *Strong technical knowledge—experience with Trackwise application, a plus. * 5. *Experience working in a highly regulated environment; GxP, QSR framework preferred. * 6. *Solid project and organizational skills. Ability to multi-task. Must have strong analytical problem solving skills. * 7. *Excellent communication including written, verbal, and listening skills. * 8. *Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision. * -- Thanks & Regards, Kalyan, Tel:913-538-5491 913-660-0395 Metapro IT Solutions Email: [email protected] Yahoo IM: kalyancbresumes --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.co.in/group/us_itgroups?hl=en -~----------~----~----~----~------~----~------~--~---
