Sr Software QA Tester | Manual Testing | CRO

Mmsh Clinical Research; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Mmsh Clinical Research seeks an experienced QA/Testing professional to lead and support testing of clinical systems, ensuring compliance with GxP and 21 CFR Part 11. The role requires mentoring teams, creating tests, and tracking defects with senior leadership updates.

You will collaborate with IT, QA, and Functional Leads to ensure end-to-end test coverage and regulatory alignment across SDLC/STLC activities. Mumbai or Hyderabad presence may be considered.

Qualifications

• 5-8 years of experience in Software Quality/Testing in clinical domain.
• Knowledge of GAMP 5, GxP, 21 CFR Part 11 and related regulations.
• Excellent documentation and communication skills.
• Detail-oriented, process-driven, proactive in identifying test scenarios and risks.
• Experience with test planning, scripting, and defect management.

Responsibilities

• Lead and support testing across clinical systems; act as SME.
• Create, review, and manage Test Plans, Scripts, and Test Reports.
• Ensure compliance with regulatory guidelines (GxP, 21 CFR Part 11).
• Collaborate with IT, QA, and Functional Leads to meet requirements.
• Mentor others on testing approaches and SDLC/STLC practices.
• Maintain defect trackers and provide status updates to leadership.
• Communicate issues to end-users and support product-related questions.
• Contribute to test planning, CI/CD adoption, and process improvements.
• Ensure timely delivery of project deliverables and approvals.

Skills

Software Testing

Quality Assurance

SDLC/STLC

Documentation

Communication

Education

Bachelor's degree in science/clinical field

Tools

Defect Tracking Tools

Job description

Roles Responsibilities

• Lead and support Computer System/Software testing activities across clinical systems utilized by MMS. Acts as SME as related to testing.
• Create, review, and manage test documents such as Test Plans, Test Scripts, Traceability Matrix, and Test Reports.
• Ensure compliance with User Requirements, GxP, 21 CFR Part 11, and other regulatory guidelines related to system use in clinical environments.
• Collaborate with IT, QA, and Functional Leads to ensure user and system requirements are met during system implementation or changes.
• Maintains a strong understanding of SDLC and STLC, Defect Lifecycle practices and guidelines; mentors others; advises on testing approach as needed.
• Proficient in authoring test related documents, i.e. Plans, Scripts, etc. independently; mentors others; acts as SME.
• Ability to support document development (SOPs/ WPs).
• Creation, updates, timely maintenance of multiple Software/System defect trackers, status presentations to senior leadership.
• Communicate with various users across the organization on issues related to product.
• Supports the capture of project requirements.
• Review and proactively provide feedback on scoped requirements, design solutions.
• Execute assigned tasks with high quality, integrity, and attention to detail.

• Interact regularly with a broad range of stakeholders, communicating proactively and clearly, including technical and non-technical subjects.
• Communicates with end-users on issues related to product support, can manage support issues though to resolution.
• Proactively applies process to identify, initiate, and write test-plans, to support quality across product development.
• Proactively applies the application of CI/CD to support quality features/product development.
• Actively contribute to testing processes, drives continual improvement, leads meetings, and actively develops knowledge in others.
• Create, reviews and provides guidance to ensure consistency in a test, and QA, best practice, and standards, supporting more junior colleagues in these activities.
• Contribute to development of, and may perform review of current policies, procedures and company standards.
• Anticipates potential quality and compliance issues and seeks appropriate support to address/mitigate.
• Ensure project deliverables are completed within agreed timescale and are formally accepted by appropriate stakeholders.
• Agree approach with stakeholders on a variety of projects and liaise with Manager to prepare realistic plans.
• Understand all workflows and dependencies for the development of project timelines.
• Actively participate in all stages of the project and understands all workflows and dependencies of project timelines.
• Identifies risks, proactively mitigating, advising team members where applicable.
• Ensures quality reviews occur according to procedure via the testing and QA function.
• Support team and company related activities and initiatives.

Job Requirements

• Graduate degree in scientific, medical, clinical discipline or related field, or related experience.
• 5-8 years of experience in Software Quality/Testing. Prior experience in clinical research or pharmaceutical domain is a must.
• Understanding of GAMP 5, GxP, 21 CFR Part 11 and other applicable regulations.
• Excellent documentation and communication skills.
• Detail-oriented, process-driven, and proactive in identifying test scenarios, risks or gaps.
• Excellent ability to multitask, attention to detail, and organizational skills.
• Excellent ability to understand technology/software and design testing approach.

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