03 Oct
|
Sandoz
|
Hyderabad
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this recent and ambitious path, unique prospects will present themselves, both professionally and personally. Join us, the future is ours to shape
The eCompliance Manager is responsible for providing Quality Assurance oversight, governance, and expert guidance for the validation of computerized systems (CSV) and qualification of IT infrastructure supporting GxP-regulated processes. The role ensures compliance with applicable regulatory requirements, including GxP, 21 CFR Part 11, Annex 11, and other relevant regulations, as well as adherence to the Sandoz Quality Management System, Quality Manual, and global procedures.
The eCompliance Manager serves as the primary Quality partner for technology and infrastructure initiatives, providing compliance oversight throughout the system lifecycle.
This includes supporting projects and operational teams by interpreting regulatory requirements, advising on validation and qualification strategies, and ensuring implementation of risk-based and compliant solutions.
Job Description
Major accountabilities:
Provide Quality Assurance oversight for Computerized Systems Validation (CSV) and IT Infrastructure Qualification activities. Ensure compliance with GxP, 21 CFR Part 11, Annex 11, data integrity requirements, and Sandoz quality standards.
Review and approve GxP-impacting changes, deviations, CAPAs, periodic reviews, supplier qualification assessments, and validation/qualification documentation.
Support global projects and operational teams with expert guidance on validation, qualification, and compliance requirements. Review and approve key validation and qualification deliverables for computerized systems and infrastructure projects.
Assess compliance risks and recommend appropriate mitigation strategies. Drive conti
📌 Ecompliance Manager Hyderabad
🏢 Sandoz
📍 Hyderabad