Description

You will perform manual functional testing for enterprise applications or SaaS products within regulated environments.

Responsibilities

• Validate test results against acceptance criteria in collaboration with cross-functional teams.
• Participate in Agile ceremonies including sprint planning, retrospectives, and backlog grooming.
• Execute User Acceptance Testing (UAT) and support release readiness activities.
• Maintain structured documentation of test results and status reports for stakeholders.
• Ensure test coverage for GxP-compliant applications aligned with FDA, EMA, and 21 CFR Part 11 standards.

Required Skills

• 4–6 years of experience in manual functional testing of enterprise applications or SaaS products.
• Strong understanding of STLC, SDLC, and risk-based testing methodologies.
• Familiarity with regulatory frameworks including GxP, GAMP, or 21 CFR Part 11.
• Experience working in Agile environments using Scrum or Kanban.
• Proficiency with test management tools such as Jira or SnapseRT.
• Working knowledge of Confluence, SharePoint, or similar documentation tools.
• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.

Preferred Skills

• Exposure to Healthcare, Life Sciences, or Pharmacovigilance systems.
• Experience with PV tools such as Argus Safety, Veeva Vault, or ARIASg.
• Basic SQL knowledge for backend validation.
• Experience with test automation or Selenium.
• Understanding of PV processes like case processing or safety reporting workflows.
• Exposure to validation documentation such as IQ/OQ/PQ, RTM, or FRS.

Key Skills

Education

Any Graduate