US-CA-SanJose: Senior SQA SAP Validation Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Senior SQA SAP Validation Engineer
* Responsibilities include, but not limited to, development of Validation project plan, risk assessments, IQ/OQ/PQ protocols, traceability, final reports and other required documentation. Coordinate and interact with all affected personnel, including consultants, in the execution of validation protocols and gathering of test data.
* Ensure all protocol executions are documented and recorded in accordance with company Quality Policies, Quality Standards and SOPs.
* Analyze data to determine if it meets protocol acceptance criteria and document deviations as necessary. Ensure all final reports are documented and approved.
*Minimum of 3 years of experience validation of SAP systems
*Minimum 5 years as experience in software testing
*Solid understanding of QA processes, approaches, methodologies
*Root cause analysis of issues, deviation management
*Good understanding of FDA regulations pertaining to computer systems validation (CFR Part 11) and cGMPs
*Working knowledge of the following SAP modules: MM, QM, SD and PP Participated in the implementation and production support of SAP
*Working knowledge of SAP development lifecycle, including design, development, testing, and release management
*Working knowledge of SQA tools, including test automation, requirements and test case management, and defect tracking
*Experience with Mac, Windows, and Unix environments
*BA BS degree or equivalent work experience in Computer Science or related field
*Experience in coordinating all aspects of software testing, developing test plans,matrices, cases, scripts, data, etc
*Must posses excellent analytical and troubleshooting skills
*Must be self-motivated, willing to learn new concepts, technologies and products quickly
*Exceptional interpersonal, writing and communication skills
*Dedication to customer service and satisfaction
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI