Leads manual software and computer system testing for clinical systems, including test planning, scripting, traceability, defect tracking, requirements review, validation, and compliance with GxP, GAMP 5, and 21 CFR Part 11. Collaborates with technical and business stakeholders, supports user issues through resolution, manages quality documentation, identifies risks, mentors colleagues, and drives testing process improvements across clinical research projects.
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
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 preferred.
- 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.
Note:
- This is a manual testing role. NO Automation testing involved at this time.
- Need to work till 1pm to 10pm IST
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