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*Application Validation Lead:-* *Duration:- Vernon Hills IL* *Duration:- 2 months* *Interview:- Phone and face to face* Submission Date: 07/17/2009 GIT Team: Quality Compliance/Office of Risk & Effectiveness Desired Start Date: 08/10/2009 End Date 12/31/2009 Number of Positions wanted: 1 Work Location: Vernon Hills Expected Hours (per week): 40 Funding Approved (Y/N) Y Is Funding Capex or Opex CAPEX Role Needed / Job Description (Please provide sufficient detail as what this consultant is to produce from a work product or Service expectation from a response time if appropriate) PMDA (Pilgrim) Application Validation Lead Act as Validation Lead for PMDA (Pilgrim) Complaint System application project. *Critical Job Responsibilities*: 1. Generate 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 SDLC. Ensure quality validation processes are executed as defined by procedures. 3. Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project. 4. Generate Change Control documentation with associated tests required. 5. Manage validation testing, generate test scripts, as needed. Execute testing as required. May coordinate team of testers. 6. May assist in gathering, understand and document business objectives, specifications and requirements on enterprise/cornerstone and/or large size projects. 7. Collaborate with business, quality, and technical individuals throughout project in generation of project / validation required deliverables. Specific Qualifications Required (specialized skills, degrees, certification, etc.) *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 both infrastructure qualification and 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 background—preferably with Clinical systems and applications.* 5. *Experience working in a highly regulated environment; GxP, QSR framework preferred. * 6. *Solid project 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.* 9. *Knowledge of PMDA (Pilgrim) Complaint system a plus.* Percent Travel Required: 0 Message to Staffing (if this requisition requires specific instructions, please add here) *Thanks & Regards* * ------------------------------ * *PRAMOD* *APPOSITE SOLUTIONS ** **| **www.iapposite.com* <http://www.iapposite.com/>* * 620 Herndon Pkwy · Suite 200 · Herndon VA 20170 *E *[email protected] · *P* 703.880.8581 · *F* 866.681.8112 · *YIM:* kukkidixit <[email protected]> ** *PLEASE SEE OUR HOTLIST @** **http://hotlist.iapposite.com*<http://hotlist.iapposite.com/> ** ------------------------------ --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "OCP_DBA" 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/OCP_DBA -~----------~----~----~----~------~----~------~--~---
