Sr. eCompliance Specialist – Computerized Systems Validation (CSV)
Location: Hyderabad, India
Experience Level: Senior
Work Mode: On-site
Job Type: Full-Time
Job Summary
Novartis is seeking a Sr. eCompliance Specialist with expertise in Computerized Systems Validation (CSV) to ensure Quality Assurance oversight for GxP systems. This role involves providing compliance guidance, reviewing validation deliverables, and supporting regulatory and audit activities. Ideal for professionals with deep knowledge of 21 CFR Part 11, GxP, DI compliance, and pharmaceutical IT systems.
Key Responsibilities
Provide QA oversight for project and operational activities related to GxP computerized systems
Review and approve CSV documentation including change controls, periodic reviews, deviations, and CAPAs
Act as the key point of contact for CSV and eCompliance matters between IT and business units
Support VMP creation and execution for associated GxP systems
Ensure audit readiness by maintaining up-to-date and compliant documentation
Conduct supplier qualification assessments and compliance reviews
Collaborate with cross-functional stakeholders to maintain validation quality
Contribute to implementing and enhancing Quality Systems and documentation practices
Identify compliance gaps and proactively support development of mitigation strategies
Required Skills & Qualifications
Strong understanding of GxP regulations, 21 CFR Part 11, and data integrity (DI) standards
Hands-on experience with computerized system validation (CSV) in a regulated environment
Knowledge of Quality Systems and CAPA management
Ability to review technical documentation for regulatory compliance
Excellent collaboration and communication skills across IT, QA, and business teams
Familiarity with pharmaceutical QA frameworks and audit processes
Bachelor’s degree in Life Sciences, Computer Science, Pharmacy, or related field
Perks & Benefits
Competitive compensation package
Comprehensive healthcare and wellness benefits
Structured learning and development programs
Inclusive work culture driven by innovation and collaboration
Access to Novartis Life Handbook for detailed benefits and rewards
Employee support programs and internal mobility opportunities
Company Description
Novartis Healthcare Pvt. Ltd. is a global healthcare innovator committed to improving lives through science-based solutions. With a focus on compliance, quality, and breakthrough therapies, Novartis continues to set industry standards in pharmaceuticals and digital health innovation.
Work Mode
On-site – Hyderabad Office
Call to Action
If you have a strong background in CSV, GxP compliance, and pharmaceutical QA, this is your chance to join a global leader in healthcare innovation. Apply now to elevate your impact with Novartis.
Discover more opportunities at ThePharmaDaily.com.
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