Manual QA Tester

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.