PROJECT MANAGEMENT, LIMS Testing, GxP Testing

- 14+ years of experience in Life Sciences with CSV / Validation for GxP systems 2. Serve as a subject matter expert for Quality Engineering practice on IT systems and solutions, including:
- Clinical Trial Management Systems (CTMS): Veeva CTMS, Medidata Rave, Oracle Siebel
- Regulatory Platforms: Veeva Vault RIM, Veeva Vault
- Laboratory Information Management Systems (LIMS): LabVantage, LabWare, STAR LIMS
- Supply Chain: Kinaxis 3. Knowledge of key Pharma regulations including 21 CFR Part 11, EU Annex 11, CSA, 21 CFR Part 820, GAMP5 principles.
- Know-how of compliance with FDA, EMA, ICH, and other regulatory frameworks for Life Sciences.
- Participate in business development activities, including proposals, solution demos, and client workshops 6.



Must have experience using Test management tools like ALM, qTest, JiRA 7. Solid hands-on experience in CSV / CSA deliverables & lifecycle including: a.

Validation

Plan b. URS, FRS analysis c. Risk assessment d. Val IQ, OQ, PQ test cases creation, updates & execution 8. Familiarity with Valgenesis or Kneat is nice to have.
- Familiarity with cloud technologies (AWS, Azure), data standards (GDPR, HL7), and cybersecurity in regulated environments.
- Strong communication, interpersonal skills. Ability to work independently and with cross-functional teams is preferred.

📌 PRINCIPAL CONSULTANT - LIFESCIENCES (Bengaluru)
🏢 Infosys
📍 Bengaluru