Senior Regulatory Compliance Specialist

11 hours ago

Hyderabad, Telangana, India beBeeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Overview

We are seeking a highly skilled eCompliance Specialist to join our team. The ideal candidate will have a strong background in regulated computerized systems and excellent communication skills.

Responsibilities
  • Provide quality oversight of project and operational activities related to GxP systems.
  • Ensure that all applicable Novartis and regulatory requirements are met for GxP regulated computerized systems projects.
  • Act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems.
  • Review and approve project related documents for GxP relevant systems, including determination of GxP applicability.
  • Establish trusted partnerships with assigned IT Function and provide day-to-day operational support.
  • Review and approve GxP impacted deviations and ensure appropriate CAPA are implemented.
  • Contribute to the preparation of VMP and execute the plan for systems associated with respective functions.
  • Review and approve Periodic Review Reports for GxP computerized systems and associated gaps within CAPA Management System.
  • Perform supplier qualification assessment activities.
Requirements
  • 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within regulated functions such as IT Quality and Compliance.
  • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
  • Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.
  • Experienced in the operational management of GxP solutions, including its related technologies to support operation.
  • Experience in GxP supplier qualification activities.
  • Good understanding in system application management, its Quality support approach, and industry best practices (ITIL, ITSM, etc.).
  • Experienced in the development, implementation, and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial, and Infrastructure space.

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