Senior Computer System Validation (CSV) Consultant - GxP Systems
Tata Consultancy Services
Job Description
Join our team as a Senior Computer System Validation (CSV) Consultant and play a key role in ensuring compliance, quality, and innovation across global Life Sciences and R&D environments.
We are seeking an experienced professional with a strong background in GxP-regulated systems, validation methodologies, and risk-based compliance practices. This is an excellent opportunity to work on cutting-edge projects involving digital transformation, AI-enabled solutions, and global R&D platforms.
Qualifications
- Bachelor's Degree in Science, Technology, Pharmacy, or a related field.
- 8+ years of overall professional experience.
- Minimum of 5 years of hands-on experience in Computer System Validation (CSV) for GxP-regulated systems.
Key Skills & Experience
Core CSV Expertise
- Strong knowledge of:
- 21 CFR Part 11 and 21 CFR Part 820
- GxP regulations
- GAMP 5
- SOX compliance
- EU Annex 11 and Annex 22
- ISO 9001
- ITIL framework
- Experience with:
- Audit and inspection readiness activities
- Periodic system reviews
- Access roster reviews
- Audit trail reviews
- Deviation and CAPA management
- SOP and policy compliance processes
- Proven experience authoring and reviewing:
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Validation Plans
- Validation Protocols
- Validation Reports
- Final Summary Reports
- High-level understanding of Veeva Vault Suite applications.
- Experience with risk-based testing methodologies aligned with CSA (Computer Software Assurance) principles.
Research & Development (R&D)
High-level understanding of:
- Biostatistics
- Clinical Research
- Drug Discovery
- Medical Affairs
- Pharmacovigilance
- Regulatory Affairs
- RPA GxP Bots
- AI-enabled GxP solutions in R&D environments
What You Can Expect From Us
- Continuous professional development aligned with your career goals.
- Opportunities for international experience.
- A collaborative, diverse, and innovative work environment.
- Exposure to global projects and cutting-edge technologies.
- Strong focus on career growth, learning, and professional advancement.
Benefits
Health Insurance
Dental Plan
Life Insurance
Transportation Allowance
Meal/Food Allowance
Childcare Assistance
TotalPass
24/7 Employee Assistance Program (psychological, legal, and financial support)
Certification Reimbursement
Learning Platform with free training and courses
Employee Referral Bonus Program
Recognition Program
Mentorship and Career Development Platform