Location: Pune (at least 3 days a week in office)
Job Type: Full-Time
About Krishagni:
Founded in 2009, Krishagni is a software product company specialising in medical research. Our flagship product, OpenSpecimen, is trusted by over 100 customers across 20 countries. We are a close-knit team of 15+ professionals, operating with a flat hierarchy and a culture free from office politics. At Krishagni, we value performance and innovation and reward excellence generously.
Key Responsibilities:
Key Responsibilities:
✅ LIMS QA & Validation:
- Lead the QA strategy, test planning, and execution for LIMS implementations and upgrades.
- Develop and execute test cases, scripts, and validation protocols (IQ, OQ, PQ).
✅ Defect Management & Troubleshooting:
- Identify, track, and resolve bugs, discrepancies, and performance issues.
- Work closely with developers and business analysts for bug fixes and enhancements.
✅ Regulatory Compliance & Documentation:
- Ensure LIMS validation follows FDA, HIPAA, GDPR, and other industry standards.
- Maintain detailed validation documentation, risk assessments, and SOPs.
✅ Collaboration & Stakeholder Management:
- Work with scientists, lab managers, IT teams, and vendors to optimize LIMS performance.
- Support user acceptance testing (UAT) and end-user training on LIMS functionality.
✅ Process Improvement & Automation:
- Implement test automation strategies for LIMS validation.
- Continuously improve QA methodologies for efficiency and compliance.
Required Skills & Qualifications:
✔ Education: Bachelor’s or Master’s in Computer Science, Life Sciences, Bioinformatics, or a related field.
✔ Experience: 5+ years in LIMS QA, software testing, and validation.
✔ Strong understanding of SDLC, Agile methodologies, and Computer System Validation (CSV).
✔ Hands-on experience with LIMS platforms (e.g., LabWare, STARLIMS, LabVantage, Thermo Fisher SampleManager, etc.).
✔ Knowledge of automation tools (e.g., Selenium, TestComplete) and scripting (Python, Java, etc.).
✔ Familiarity with GAMP 5, CFR Part 11, ISO 13485, ISO 17025, and GMP/GLP.
✔ Strong analytical, problem-solving, and documentation skills.
✔ Excellent communication and stakeholder management abilities.
To apply: Email your resume to [email protected].