*Hello Business Partners,* Keen Infotek, Inc have an urgent requirement as follows: Please direct your email to the listed recruiter We appreciate your assistance.
Email: Thomas ***** **[email protected]* ***** **PLEASE SEND ME RESUME WITH FOLLOWING DETAILS IN THE SAME EMAIL TO AVOID DELAY IN SUBMISSION - THANKS IN ADVANCE* Total IT : Total US Experience: Full Name : Location : Contact Number : Email : Availability : Rate on C2C/W2/1099 : Visa Status : Updated Resume: Employer Details: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- *REQUIREMENT DETAILS :-** * Quality Compliance Validation Lead ( QTS / TRACEWISE PROJECT ) Vernon Hills , IL Duration : 8 Months+ Rate : open *Purpose of the Position*: 1. 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, 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* *Thomas Fedrick **Recruiting Specialist "IT Services"* *[image: cid:[email protected]]* *710 E || Ogden Ave || Suite #110 || Naperville || IL 60563 || Ph: 630-225-7137 || Fax: 630-206-0325 *[email protected] || www.keeninfotek.com http://www.linkedin.com/in/thomasfedrick *[image: Standard Business Partner emblem]* Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with "remove" and include your "original email address / addresses" in the subject heading. Include complete address/addresses and/or domain to be removed. We will immediately update it accordingly. We apologize for the inconvenience if any caused. --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Oracle-Distribution" 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.com/group/Oracle-Distribution -~----------~----~----~----~------~----~------~--~---
