PRINCIPAL CONSULTANT - LIFESCIENCES

Roles & Responsibilities.

• 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.


• 4. Know-how of compliance with FDA, EMA, ICH, and other regulatory frameworks for Life Sciences.


• 5. 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. Strong 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.


• 9. Familiarity with cloud technologies (AWS, Azure), data standards (GDPR, HL7), and cybersecurity in regulated environments.


• 10. Strong communication, interpersonal skills. Ability to work independently and with cross-functional teams is preferred.

Technical RequirementPROJECT MANAGEMENT, LIMS Testing, GxP Testing

Educational RequirementBachelor of Engineering

Preferred SkillsDomain->LifeSciences->LifeSciences - ALL,Foundational->Project Management->Project Management,Technology->Life Sciences->LIMS

Service LineInfosys Quality Engineering