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Please let me know on darshan@riderconsultinginc.com if you have any good resources for the below position mentioned.
Role: QA Test Lead
Location: Waukegan, IL
Duration: 6 Months Contract
Start: Immediate
Interview: Phone
Job Description:
CORE JOB RESPONSIBILITIES:
· Experience in Creating Validation Change Requests, Developing Validation Plan, Summary Reports, Traceability Matrix and other project documents created during Computer Systems Validation Processes
· Independently conduct, review and evaluate computerized systems for Privacy, System Risk and Part 11 Compliance
· Leads Validation related tasks and activities within a client area, providing oversight on a project or multiple projects
· Ensures that project documentation is in compliance with pharma client’s policies and procedures
· Develops the testing strategy for large and medium sized projects and develops the overall Validation plans and timetables.
· Develops business relationships with internal IT and QA team members to ensure successful implementation and support of project efforts by ensuring consistent IT Compliance practices.
· Create/Develop test plan, testing strategies and test protocols per approved User and Functional Requirements
· Organize, coordinate and gather requirements to perform Functional, Integration and/or Regression tests
· Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)
· Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager
· Strong knowledge of GxP’s and industry validation standards
· Perform system assessment activities to formulate validation plans and strategies
· Ability to coordinate/facilitate approval of validation documentation independently
Skills/Experience Requirements Basic Qualifications:
· 5 to 7 years of experience in the Pharmaceutical industry in Clinical area preferred.
· Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
· Excellent verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment including SDLC.
· A proven record for success in Computer System validation.
· Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
· Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
· Excellent attention to detail and time management skills.
· Ability to work independently and with work teams
· PC literate with the following applications: MS Excel, Word, PowerPoint
· Significant Work Activities & Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
· Experience with Quality Center (HP Quality Center) preferred.
Darshan Patel
Ph No:- 850-810-5234
E-mail : darshan@riderconsultinginc.com
G-Talk : darshan.rider1@gmail.com
Web: www.riderconsultinginc.com
