01 Aug
|
Recognized
|
Indore
Job Description – QA Tester
Position: QA Tester
Location: Indore, India
Experience Required: 5+ years
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.