Job Description – QA Tester
Role Overview
We are seeking an experienced QA Tester with a strong
background in testing GxP/GMP-regulated computerized systems within the
pharmaceutical, biotech, or life sciences industry. The ideal candidate will
have hands-on experience in testing applications for compliance with regulatory
requirements such as 21 CFR Part 11, GAMP 5, and Annex 11. This role
involves ensuring that all computer system applications are thoroughly tested,
documented, and validated to meet business, technical, and compliance
requirements.
Key Responsibilities
- Develop,
review, and execute test plans, test cases, and test scripts for
GMP-regulated computer systems and applications.
- Ensure
testing activities comply with GxP, GMP, CSV (Computer System
Validation), and data integrity requirements.
- Collaborate
with business analysts, developers, and validation teams to understand
requirements and system design.
- Perform functional, regression, integration, and user acceptance testing (UAT) of applications.
- Document
and report defects in a structured manner and ensure timely resolution.
- Support
the preparation and review of validation deliverables (e.g.,
Requirements Traceability Matrix, Test Summary Reports).
- Ensure
adherence to SOPs, quality standards, and regulatory guidelines throughout the testing lifecycle.
- Participate
in audits/inspections and provide evidence of testing and validation
compliance.
- Continuously
identify opportunities for test process improvements and automation
where applicable.
Required Qualifications
- Bachelor’s
degree in Computer Science, Information Technology, Life Sciences, or
related field.
- 5+
years of experience as a QA Tester in a regulated environment
(pharmaceutical, biotech, or medical devices).
- Strong
knowledge of GMP, GxP, CSV, 21 CFR Part 11, Annex 11, and GAMP 5
guidelines.
- Hands-on
experience with test management tools (e.g., HP ALM/QC, Jira,
TestRail).
- Experience
writing and executing detailed test scripts with clear
documentation.
- Strong
understanding of Software Development Life Cycle (SDLC) and System
Development Life Cycle (SDLC) methodologies (Agile, Waterfall,
V-model).
- Excellent
communication skills with ability to work in cross-functional teams.
Skills Required
- Bachelor's degree in Computer Science, Information Technology, Life Sciences, or related field
- 5+ years of experience as a QA Tester in a regulated environment (pharmaceutical, biotech, or medical devices)
- Strong knowledge of GMP, GxP, CSV, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines
- Hands-on experience with test management tools (HP ALM/QC, Jira, TestRail)
- Experience writing and executing detailed test scripts and documenting results
- Strong understanding of SDLC and system development methodologies (Agile, Waterfall, V-model)
- Excellent communication skills and ability to work in cross-functional teams
What We Do
Technology, society, economy, policy – all moving at breakneck speed in our 21st century world. You’re feeling the pressure to quickly implement new business models, find new value, make split-second informed decisions and keep one step ahead of customers. How? The answer lies in the ability to make quick, accurate and sustainable business decisions. We believe digital offers a way of doing things better – but the journey to transformation doesn’t have to be painful. At Aligned Automation, we work hard to digitally enable your business strategy – connecting processes, technologies and people to unlock value and drive critical business outcomes.
