Life Science (LIMS/CSV) Testing Consultant
Infosys
You will play a pivotal role in shaping and delivering high-impact LIMS and CSV solutions for global life sciences and pharmaceutical clients. Leveraging your deep expertise in GxP environments, you will guide customers through their digital quality and laboratory transformation journeys, ensuring systems are compliant, efficient, and future-ready. In this role, you will collaborate closely with cross-functional teams—business stakeholders, QA, IT, and vendors—to design robust solutions that align with regulatory expectations and business goals.
As a senior member of the team, you will mentor consultants, drive best practices, and bring structure and clarity to complex projects. You will have the opportunity to influence strategy, standardize methodologies, and contribute to reusable frameworks and accelerators. If you enjoy solving complex problems, leading from the front, and creating tangible value in regulated environments, this role offers a platform to make a meaningful impact while working in a collaborative, supportive culture.
LIMS & CSV Solution Leadership
- Lead end-to-end implementation, enhancement, and support of LIMS solutions for pharma/biotech clients.
- Define and execute Computer System Validation (CSV) strategies, including validation plans, test strategies, and traceability matrices.
- Ensure all LIMS and related systems are implemented in alignment with GxP, 21 CFR Part 11, Annex 11, and relevant regulatory expectations.
- Conduct impact assessments and risk-based validation for system changes, upgrades, and new deployments.
- Requirements, Design & Stakeholder Management
- Engage with business stakeholders to gather, analyze, and document requirements for laboratory and quality processes.
- Translate business needs into functional and technical specifications for LIMS and associated systems.
- Facilitate workshops, walkthroughs, and design sessions with cross-functional teams and client SMEs.
- Act as primary point of contact for client stakeholders, managing expectations, scope, and priorities.
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