PRINCIPAL CONSULTANT - LIFESCIENCES

Infosys; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Infosys Quality Engineering in Bengaluru seeks a Life Sciences QA expert with 14+ years of CSV/Validation for GxP systems. You will serve as SME for IT systems, lead regulatory compliance initiatives, and contribute to business development through proposals and workshops.

You will collaborate with cross-functional teams, manage test deliverables, and ensure adherence to 21 CFR Part 11, EU Annex 11, CSA, ICH guidelines. Familiarity with ALM, qTest, Jira and cloud platforms is preferred.

Qualifications

• 14+ years of Life Sciences experience with CSV/Validation for GxP systems.
• Experience as a subject matter expert for Quality Engineering on IT systems and solutions.
• Knowledge of regulatory frameworks and standards (FDA/EMA/ICH).

Responsibilities

• Serve as SME for Quality Engineering on IT systems and solutions.
• Participate in business development activities, proposals, solution demos, and client workshops.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, CSA, and 21 CFR Part 820 in Life Sciences projects.
• Lead CSV/CSA deliverables & lifecycle including validation plans and test case execution.
• Collaborate with cross-functional teams and manage cross-domain projects.

Skills

Life Sciences

CSV / Validation

GxP Knowledge

Regulatory Compliance

Quality Engineering

Communication

Education

Bachelor of Engineering

Tools

ALM

qTest

JIRA

Job description

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 Requirement

PROJECT MANAGEMENT, LIMS Testing, GxP Testing

Educational Requirement

Bachelor of Engineering

Preferred Skills

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

Service Line

Infosys Quality Engineering