Consultant – Third Party Risk Management (CSV) | Deloitte India | Pune
Job Description
Summary
Deloitte India is hiring a Consultant – Third Party Risk Management (Computer System Validation/CSV) in Pune. This role is ideal for professionals with experience in IT Quality, GxP compliance, regulatory standards, and validation of computerized systems in pharmaceutical and healthcare industries. You’ll help global clients strengthen compliance, manage risks, and ensure adherence to critical regulations like FDA, MHRA, 21 CFR Part 11, and GxP guidelines. At Deloitte, you’ll work in a collaborative environment, mentor teams, and contribute to impactful projects in the Technology & Transformation practice.
Job Details at a Glance
| Detail | Information |
|---|---|
| Job Title | Consultant – Third Party Risk Management (CSV) |
| Company | Deloitte South Asia LLP |
| Location | Pune, India |
| Department | Technology & Transformation – Risk & Compliance |
| Job Requisition ID | 77183 |
| Designation | Consultant |
| Experience | 2 – 8 years |
| Shift/Timing | Standard business hours |
| Key Focus Areas | IT Quality, CSV, GxP, FDA/MHRA compliance, Risk Assessments |
| Education | B.E., B.Tech, MCA, MBA, M.Sc, B.Pharm, M.Pharm (or equivalent) |
Responsibilities
As a Consultant – CSV & Third Party Risk Management at Deloitte Pune, you will:
- Design and implement IT quality systems frameworks.
- Manage reviews, risk assessments, and compliance audits for IT quality and GxP processes.
- Support Computer System Validation (CSV) across pharmaceutical, healthcare, and medical device industries.
- Define and execute validation strategies for IT software and platforms.
- Participate in validation lifecycle activities: authoring documentation, requirements definition, traceability matrix creation, protocol development, testing, and deviation management.
- Ensure compliance with 21 CFR Part 11 for computerized systems.
- Develop and improve SOPs, guidelines, and IT compliance assessments.
- Conduct gap analyses and provide remediation plans for compliance risks.
- Deliver user training on CSV and compliance awareness.
- Coach and mentor team members while managing multiple client engagements.
Skills Required
- Strong expertise in IT Quality, Regulatory, and Compliance (IT-QRC).
- Knowledge of global regulatory bodies: FDA, MHRA and related guidelines.
- Hands-on experience in GxP practices, GAMP5 guidelines, CSV for COTS products (e.g., COGNOS, IMPACT, BAELN).
- Understanding of 21 CFR Part 11 and FDA GxP regulations.
- Proficiency in business analysis, risk identification, FRS creation, and validation testing deliverables.
- Excellent verbal and written communication skills.
- Consulting experience with global clients (preferred).
Qualifications
- Education: B.E., B.Tech, MCA, MBA, M.Sc, B.Pharm, M.Pharm (or equivalent).
- Experience: 2 – 8 years in IT quality, CSV, or compliance-focused roles.
Why Deloitte?
At Deloitte India, you’ll work with global clients to build strong compliance programs, minimize risk, and deliver transformative solutions. With access to learning, mentoring, and career development, you’ll grow while making an impact that matters.
Apply Now
Take the next step in your career as a Consultant – Third Party Risk Management (CSV) at Deloitte Pune.
👉 Apply directly on Deloitte Careers