ECompliance Management Position

1 week ago

Hyderabad, Telangana, India beBeeEcompliancemanager Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Opportunity: ECompliance Manager

We are seeking an experienced ECompliance Manager to join our team. As a key member of our organization, you will play a vital role in ensuring the quality of operational activities related to GxP systems.

Main Responsibilities:
  • Oversee the quality of operational activities for GxP systems, including changes, periodic reviews, and deviations.
  • Provide support to meet regulatory requirements for GxP regulated computerized systems projects.
  • Serve as the primary 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.
Key Requirements:
  1. xP relevant computerized systems must be developed, implemented, and maintained according to Novartis requirements. Timely review and approval of changes, deviations & periodic review reports for the GxP computerized systems is essential.
  2. Documentation supporting eCompliance and CSV requirements must be in place, up-to-date, and readily available during audits and inspections.
  3. Gaps in eCompliance and CSV activities must be proactively identified, escalated, and mitigation plans supported.
  4. Client/stakeholder satisfaction and feedback.
Desirable Qualifications:
  • A minimum of 10-15 years of overall IT experience, with at least 7 years in the Pharmaceutical Industry and within regulated functions such as IT Quality and Compliance.
  • A solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
  • Solid experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.

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