Requirements:
1 to 3 years of experience with enterprise software product development lifecycle/phases.
Strong experience in Functional testing of all test phases, including test strategy, test design.
Solid understanding of GxP regulations and 21 CFR Part 11 / EU Annex 11 compliance and familiarity with Validation Protocols (IQ, OQ, PQ) is a plus.
Previous experience working within the Pharmaceutical, Biotech, or Medical Devices industries and using/testing enterprise software applications like ValGenesis VLMS, eVal is highly valued.
Experience using Jira and Test Management tools (e.g. Zephyr, QMS) to manage regulated documentation.
Able to work collaboratively and independently with speed and minimal supervision.
Experience/knowledge in pharma regulatory, quality, risk, process validation software systems (e.g., GAMP 5 framework)
Experience with AI powered automation frameworks like Playwright, TestRigor etc is preferable.
Responsibilities:
Develop deep expertise in our products and their uses in the pharmaceutical industry.
Plan and execute enterprise software platform integration, system testing activities
Work with software developers and product managers in an Agile team environment.
Create and Manage test repository (scenarios, cases, steps, priorities, categories etc), test metrics, maintaining full traceability between requirements and test cases (Traceability Matrix).
Ability to map data flows in the software as a basis to develop challenging and robust testing.
Conduct QA tests and verify outcomes within schedules/timelines.
Part of a team (BA/PO, Developers, SDETs etc) that develop enterprise software applications.
Understand the business requirements and design, development/coding aspects.
Participate in the complete development life cycle
Use AI tools/capabilities to automate the generation, automation, execution of test suites
Performing test automation on multiple application platforms – Web, Mobile etc
Manage/Involve with CI/CD specific activities.
Own and be accountable for the Quality, Reliability and Compliance of the respective product deliverables.
Strive for self-excellence along with enabling success of the team/stakeholders.
Skills Required
- 1 to 3 years of experience with enterprise software product development lifecycle/phases.
- Strong experience in Functional testing of all test phases, including test strategy and test design.
- Experience using Jira and Test Management tools (e.g. Zephyr, QMS) to manage regulated documentation.
- Able to work collaboratively and independently with speed and minimal supervision.
- Experience/knowledge in pharma regulatory, quality, risk, process validation software systems (e.g., GAMP 5 framework).
- Solid understanding of GxP regulations and 21 CFR Part 11 / EU Annex 11 compliance; familiarity with Validation Protocols (IQ, OQ, PQ).
- Previous experience in Pharmaceutical, Biotech, or Medical Devices industries and testing enterprise software like ValGenesis VLMS or eVal.
- Experience with AI powered automation frameworks like Playwright, TestRigor and automated test generation/execution.
What We Do
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
