Perform and coordinate activities required to bring and maintain systems to a validated state.
Develop Test/Validation Plans and Validation Summary Reports.
Prepare, execute and review test scripts and maintain traceability matrix.
Manage defects and defect lifecycle.
Execute various testing types: Black Box, GUI, System (OQ), User Acceptance (PQ), Functional, Regression.
Work with automated testing tools (preferably Katelon) and support test automation.
Liaise with project teams and other departments on-site and remotely.
Manage multiple tasks and timelines to meet project deliverables.
Ensure compliance with regulatory guidelines (21 CFR Part 11, Annex 11, GAMP5).
Support testing of applications built with Java, .Net, Oracle, MySQL, C++.
Requirements
Minimum 5 years of experience/ 10 years of experience in software testing/validation in a regulated environment.
Ability to successfully manage multiple tasks and timelines.
Ability to effectively liaise with project team members and other teams/departments, on-site and remotely.
Ability to perform and coordinate activities required to bring/maintain systems to a validated state.
In depth knowledge of Software Development Life Cycle and its major phases.
Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability matrix, Validation Summary Report.
Proven experience in different types of testing including Black Box Testing, Graphical User Interface (GUI) Testing, System Testing (OQ), User Acceptance Testing (PQ), Functional Testing, Regression Testing.
Proven experience testing applications developed in Java, .Net, Oracle, MySQL, C++ preferred.
Proven experience with automated testing, preferably the Katelon tool.
Strong knowledge of regulatory guidelines on computerized systems: 21 CFR Part 11, Annex 11, and/or GAMP 5.
Understanding of SQL and database concepts preferred.
Experience in Test Automation Tools or Application Lifecycle Management preferred.