PRINCIPAL CONSULTANT - LIFESCIENCES

. 14+ years of experience in Life Sciences with CSV / Validation for GxP systems

1. 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

1. Knowledge of key Pharma regulations including 21 CFR Part 11, EU Annex 11, CSA, 21 CFR Part 820, GAMP5 principles.
2. Know-how of compliance with FDA, EMA, ICH, and other regulatory frameworks for Life Sciences.
3. Participate in business development activities, including proposals, solution demos, and client workshops
4. Must have experience using Test management tools like ALM, qTest, JiRA
5. 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

1. Familiarity with Valgenesis or Kneat is nice to have.
2. Familiarity with cloud technologies (AWS, Azure), data standards (GDPR, HL7), and cybersecurity in regulated environments.
3. Strong communication, interpersonal skills. Ability to work independently and with cross-functional teams is preferred.