Electronic Compliance Manager

5 days ago

Hyderabad, Telangana, India beBeeGxp Full time ₹ 25,00,000 - ₹ 30,00,000

We are seeking a Compliance Specialist to ensure the quality and compliance of our systems. Your key responsibilities will include:

Key Responsibilities
  • Oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.)
  • Support for regulatory requirements for GxP regulated computerized systems projects.
  • Point of Contact for CSV related matters for GxP Computerized Systems.
  • Review and approval of project related documents for GxP relevant systems.
  • Establish partnership with assigned IT Function.
  • Review and approval of GxP Changes and associated deliverables.
  • Review and approval of impacted deviations, ensuring appropriate CAPA implementation.
  • Contribution to preparation of VMP and execution plan for systems associated with respective functions.
  • Review and approval of Periodic Review Reports for GxP computerized systems and gaps within CAPA Management System.
Essential Requirements
  • Develop, implement and maintain xP relevant computerized systems according to Novartis requirements.
  • Maintain up-to-date documentation supporting eCompliance and CSV requirements.
  • Proactive identification, escalation and mitigation of gaps in eCompliance and CSV activities.
Desirable Requirements
  • 10-15 years of overall IT experience, with minimum 7 years in Pharmaceutical Industry and regulated functions such as IT Quality and Compliance.
  • Solid understanding of global regulations and Health Authorities expectations governing computerized systems.
  • Experience in development, implementation and lifecycle management of computerized systems in regulated environments.
  • Quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments.
  • Operational management of GxP solutions including its related technologies.
  • System application management, Quality support approach and industry best practices.
  • Development, implementation and lifecycle management of key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space.
  • Cross-divisional/functional work with complex international teams.
  • GxP supplier qualification activities.
  • Ability to adjust to multiple demands, shifting priorities and unexpected events.
  • Effective interaction and presentation to Management.
  • Stakeholder management and trust building.
  • Influence without hierarchical authority and build trusted partnerships.
  • Self-starter with experience in initiating and delivering projects and processes.
  • Excellent communication, negotiation, facilitation and interpersonal skills.

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