Sr. eCompliance Specialist

Key performance indicators :

• GXP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements.
• On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems.
• 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.
• Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported.
• Client / stakeholder satisfaction and corresponding feedback.
• 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance

Skills :

• Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)
• Good 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 the 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
• Successful cross-divisional / functional work with complex international teams
• Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
• Ability to effectively interact and present to Management
• Ability to 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

Skills Required

Sap, Csv, Audit Support, Capa