Business Test Engineer

Job Title: ERV Business Test Engineer

Career Level - D

Introduction to role

The ERV Test Engineer is accountable for delivering business testing for agreed system and configuration releases within the RIM / ERV platform.

The ERV Business Test Engineer is a business-side role, working in close collaboration with the business and IT members of the Regulatory Platform team to deliver business testing for changes to the ERV platform, ensuring the continuous improvement of the platform from the business perspective within the IT platform model. This role is performed by RIM Managers.

Context: Enterprise Regulatory Vault (ERV) is AstraZeneca's business-wide system for Regulatory Information Management (RIM). As a data-centric cloud / SaaS platform it enables compliance with current regulatory requirements and can evolve to meet future needs. This flexibility brings many benefits, but also the key challenge of a steadfast cycle of incremental and continual changes that requires ongoing investment of time and resources to ensure AZ improve utility and enables automation, digitization and agility to meet future needs.  

The ERV Business Test Engineer works in Global Regulatory Operations (GRO), which is accountable for business ownership of ERV, ensuring it is optimally developed, maintained, governed and supported across the enterprise to meet scientific, business and compliance needs.

Accountabilities :

• Conducting business testing (User Acceptance Testing (UAT) and Verification testing) for ERV, inclusive of major platform releases, minor releases and report releases

• Crafting, authoring and updating test scripts to validate ERV against user stories and business process

• Writing and editing test scripts that follow the business processes (per the user story or change control)

• Set up of test data and test pre-conditions

• Supporting the execution of test scripts

• Providing support to enable test volunteers

• Provide analysis and recommendations against test executions and test results

• Handling issues and bugs and ensuring their resolution and re-testing

• Ensure test results have been appropriately documented

• Conducting test impact assessments:

• Assessing user stories, change requests and functional risk assessments

• Identify impact on existing scripts

• Provide time required estimates for script updates, data preparation and script execution

• Experienced use of the following key tools:

• Jira / X-Ray for leading user stories, conducting testing, receiving assignments, issue resolution, raising and resolving bugs

• Excel to plan test cases, define data and connect to Visio workflows

• Project planning tools (e.g. Excel, MS Project, Smartsheet)

• Anticipating, documenting and addressing (or mitigating) issues and risks related to testing and, where appropriate, bringing up to test lead

• Develop expertise in ERV system and provide support to the Training, Change and Communications lead and Change Release Managers

• Contributing to the improvement of an effective test approach to ensure an efficient, risk based validation of the ERV system

• Establishing and leading a traceability matrix to link test cases, test scenarios, and test scripts to user stories, ensuring full coverage and traceability throughout the testing process

• Regular communication and status reporting ensuring test lead has an up to date picture of test activity progress

Essential Skills/Experience:

• Experience authoring and driving UAT (user acceptance test) scripts

• Experience interpreting business user stories (aka requirements) and translating to test scripts

• Experience with system development lifecycle of validated systems / platforms within a regulated environment

• Experience in agile system development and working within a global team

• Fluent in written and verbal English

Desirable Skills/Experience :

• Experience working with GxP regulated systems within the biopharmaceutical industry

• Experience with Veeva Vault applications, preferably the Veeva Regulatory Suite

• Knowledge of Regulatory Information Management systems and practices

• Professional qualification in software testing, e.g. ISTQB/ISEB Foundation certification

• Previous experience with AstraZeneca

• Ability to build relationships across, cultures, functions and fields to deliver a quality service