Careers

·       Author user requirements including 21 CFR Part 11 Requirements and develop test procedures as per the requirements for Enterprise Data Warehouse (EDW) and QuIn which is a Quality system.

·       Review and update functionality whenever and wherever required to enhance the performance of the system and to meet the user’s requirements.

·       Develop Operational Qualification (OQ) and Performance Qualification (PQ) protocols.

·       Record the user’s requirements and results obtained at the end of each of the testing (System testing and User Acceptance Testing) and review them from time to time to make sure user specifications were met using Traceability Matrix.

·       Prepare Validation Summary Reports (VSR) and Standard Operating Procedures (SOP).

·       Identify any deviations and gaps in the testing procedure, documentation, or configuration, and prepare recommendations for mitigation of the issues found.

·       Responsible for authoring/updating of all validation deliverables (Compliance Analysis, Validation Plan, User and Functional Requirements, Information Asset Protection Policies, Risk Assessment, Test Protocols, Test Scripts, Test Reports, Traceability Matrix, Validation Summary Reports) across the project lifecycle.

·       Provide expertise in review of all deliverables across the project lifecycle.

·       Created/Maintained Epics and User Stories in JIRA and performed testing using HP ALM and X-Ray in JIRA.

·       Ensure documentation meets quality standards according to current Good Manufacturing Practices (cGMP), applicable regulatory compliance, company, and FDA guidelines.

·       Monitor and advise on quality of all QuIn deliverables and report to management. 

Qualification: This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.