Sr. eCompliance Specialist

Overview

The Senior eCompliance Specialist provides Quality Assurance oversight and guidance on computerized systems validation (CSV) within GxP, 21 CFR Part 11 and Novartis Quality Manual requirements, and acts as the CSV point of contact between IT and the business.

What you'll do

• Provide quality oversight of project and operational activities for GxP systems, including changes, periodic reviews and deviations.
• Support meeting applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
• Support the implementation, operation and optimization of automation and AI-enabled solutions in day-to-day eCompliance activities.
• Act as point of contact for all CSV matters for GxP computerized systems and as the interface between IT and business on eCompliance topics, promoting a quality culture.
• Review and approve project documents for GxP relevant systems, including determining GxP applicability for all systems.
• Establish a trusted partnership with the assigned IT function, understanding business drivers, and provide day-to-day operational support.
• Review and approve GxP-impacted deviations and ensure appropriate CAPAs are implemented.
• Contribute to the preparation of the Validation Master Plan (VMP) and execute the plan for systems associated with the respective functions.
• Review and approve Periodic Review Reports for GxP computerized systems and the associated gaps within the CAPA Management System.
• Perform supplier qualification assessment activities.
• Provide audit support as assigned and the required Quality support for CAPAs.

What you'll need

• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent.
• 5-10 years of overall experience, and a minimum of 4 years of relevant experience in the pharmaceutical industry, particularly in regulated functions such as IT Quality and Compliance.
• Good understanding of global regulations and Health Authority 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 and their related technologies.
• Experience in GxP supplier qualification activities.

Nice to have

• Good understanding of 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 pharmaceutical development, manufacturing, quality, commercial and infrastructure.
• 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 initiating and delivering projects and processes.
• Excellent communication, negotiation, facilitation and interpersonal skills.

Details

• Location: Hyderabad (Office).