Validation Engineer Icon Chennai
30 August 2010Main responsibility will be to assist in the preparation, review and approval of an Installation Qualification Protocol (IQ) Ability to review and approve the hardware & software installation and upgrade process for new servers to ensure all installations are done properly with objective evidence/proof collected to document the process
Ability to create test scripts based on requirements and design specifications
Ability to coordinate Operational Qualification, Performance Qualification, and Regression testing activities
Ability to create a requirements traceability matrix
Ability to perform the responsibilities of the Approver role associated with all Test Scripts ensuring that objective evidence/proof is collected to prove that system requirements have been met
Ability and willingness to travel, including international and domestic
Experience & Qualifications:
Technical experience associated with the installation and configuration of hardware and software.
A working knowledge of a System Development/Delivery Life Cycle (SDLC) and general application support standards.
Must have a strong knowledge of software testing.
Must be familiar with executing ad-hoc, dry run, test script creation, formal test script execution, performance / stress testing and complete associated documentation to ensure test results are reported accurately.
Familiarity with defect tracking, approvals of defects, defect resolutions and tracking issues through resolution using defined processes.
Bachelor’s degree in computer science, mathematics, information systems, information technology or a related field, or a minimum of 1 to 2 years of testing experience based on defined requirements, using test plans and test scripts.Strong desire to learn Computer System Validation required by the FDA (USA Food and Drug Administration) for computer systems used to process clinical data.
2-4 years exp
Awareness of the FDA regulations, such as 21 CFR Part 11, and guidelines for Computer System Validation, and/or previous validation experience is a plus.
Email Address: malarkannan.j@iconplc.com,Nilamadhab.Mahapatra@iconplc.com Telephone:
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