eCompliance Manager

NOVARTIS

10 - 15 years

25 - 30 Lacs

hyderabad

Posted:8 hours ago| Platform:

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Skills Required

operations management operational support interpersonal skills manager quality assurance application management networking diversity and inclusion manufacturing quality crm auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)
2. Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. 3. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. 4. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. 5. Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. 6. Review and approve the GxP Changes and the associated deliverables. 7. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. 8. Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. 9. Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. 10. Perform supplier qualification assessment activities. 11. Provide Audit support as assigned and in case of CAPAs, provide the required Quality support.

Key performance indicators:

1. GxP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements.
2. On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. 2. Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues. 3. Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. 4. Client/stakeholder satisfaction and corresponding feedback.

Minimum Requirements:
Work Experience:

10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Complianc

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