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

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.