QA Tester- GxP/GMP
2 weeks ago
Job Description-
QA Tester (GxP/GMP Compliance)
Position:
QA Tester
Domain:
Medical / Pharmaceutical / Biotech / IT
Location:
Indore/Pune
Experience Required:
5+ years
About Aligned Automation
At AppTestify, we live by our "Better Together" philosophy to build a better world. As a strategic service provider to Fortune 500 companies, we help digitize enterprise operations and drive impactful business strategies. Our purpose goes beyond projects—we strive to deliver meaningful, sustainable change that shapes a more optimistic and equitable future.
Our culture is deeply rooted in our 4Cs—Care, Courage, Curiosity, and Collaboration—ensuring that each employee is empowered to grow, innovate, and thrive in an inclusive workplace.
Job Summary
· We are looking for skilled
Testers
with hands-on experience in
GxP/GMP-regulated environments
within the Medical/Pharmaceutical/Biotech/IT domain.
· The role involves designing and executing test scripts, documenting results in line with Computer Validation requirements and ensuring
Compliance with
Pharma Regulatory Standards.
Key Responsibilities
- Design
,
write
, and
execute
test scripts based on functional requirements and validation protocols. - Perform testing activities in compliance with
GxP/GMP
and
Validation
guidelines. - Report and track defects, ensuring timely resolution.
- Document test results,
CAPA/Deviations
, and Issues as per regulatory and organizational standards. - Collaborate with
stakeholders
, developers, and validation teams to ensure test coverage and compliance. - Support audit and inspection
readiness
through accurate and complete test documentation.
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, medical devices or IT). - Good understanding of GxP/GMP regulatory requirements and Computer Validation processes and documentation.
- Hands-on experience with
test management tools
(e.g., HP ALM/QC, Jira, TestRail). - Strong understanding of
Software Development Life Cycle (SDLC)
and
System Testing Life Cycle (STLC) methodologies
(Agile, Waterfall, V-model). - Excellent communication skills with ability to work in cross-functional teams.
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