GxP Manual Functional Tester

2 weeks ago

Pune, India Quantum Integrators Group, LLC Full time

About the Job :

We are seeking a highly skilled and experienced GxP Manual Functional Tester to join our dynamic team. In this full-time role, you will play a critical part in ensuring the quality and compliance of our software solutions within a Good Practice (GxP) regulated environment. You will be responsible for meticulously designing, executing, and reporting on manual functional tests, contributing significantly to the integrity and reliability of our systems. This role requires a strong understanding of software testing methodologies, GxP regulations, and a collaborative spirit to work effectively across various teams.

Key Responsibilities :

As a GxP Manual Functional Tester, your responsibilities will include :

- Test Strategy & Planning : Contribute to the development of test strategies and plans, ensuring alignment with project requirements and GxP compliance standards.

Test Case Design & Execution :


- Design and develop comprehensive Functional Integration Testing (FIT) test cases based on business requirements, functional specifications, and GxP guidelines.

- Execute FIT test cases thoroughly, documenting results and evidence of testing.

- Design and develop User Acceptance Testing (UAT) scenarios and test cases, collaborating closely with business stakeholders to ensure they accurately reflect user needs.

- Facilitate and support UAT execution, guiding users through test scenarios and capturing feedback.

Software Development Life Cycle (SDLC) & Agile Methodologies :


- Apply a strong understanding of the Software Development Life Cycle (SDLC) and Agile methodologies (e.g., Scrum, Kanban) throughout the testing process.

- Actively participate in Agile incremental testing, including sprint planning, daily stand-ups, and sprint reviews.

Defect Management :


- Identify, document, and track defects with precision using Jira or similar test management tools.

- Collaborate with development teams to ensure timely resolution of defects.

- Provide clear and concise defect reports, including steps to reproduce, expected results, and actual results.

Collaboration & Communication :


- Work closely with cross-functional teams, including business analysts, developers, quality assurance professionals, and regulatory affairs specialists, to ensure comprehensive test coverage and compliance.

- Communicate test progress, risks, and issues effectively to project stakeholders.

- Maintain high-quality documentation for all testing activities, ensuring traceability and audit readiness.

GxP Compliance :


- Ensure all testing activities adhere strictly to GxP regulations and internal standard operating procedures (SOPs).

Required Qualifications :


- Experience : Minimum of 5+ years of experience in manual functional testing, specifically within GxP-compliant environments (e.g., Pharmaceutical, Biotechnology, Medical Devices).

- Testing Methodologies : Good understanding and hands-on experience with :
  • Software Testing Life Cycle (STLC)
  • Functional Testing
  • Functional Integration Testing (FIT) design and execution
  • User Acceptance Testing (UAT) design and facilitation
  • Defect Management processes
- Agile Experience : Proven working experience with Agile incremental testing methodologies.

- Tools : Hands-on experience with test management and defect tracking tools, particularly Jira.

- SDLC Knowledge : Solid understanding of Software Development Life Cycle (SDLC) and Agile methodologies.

- Communication : Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly and concisely.

- Documentation : Strong documentation skills, capable of creating detailed test plans, test cases, and defect reports.

- Collaboration : Proven ability to collaborate effectively with business, development, and regulatory teams.
(ref:hirist.tech)

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