Quality Analyst I

Job Description:

Responsibilities

• Serve as initial point of contact for Veeva Global GxP business questions related to QMS and EDMS processes.
• Act as a primary business liaison with IT support (FAS) for operational support activities
• Lead updates to system-specific SOPs, WIs, CBTs as driven by business needs.
• Review and approve master data requests as needed.
• Assist with triage and review of system standard releases, new feature requests, and business enhancement requests for feasibility with IT.
• Participate in system change request/release review and prioritization meetings (Change Advisory Boards) with IT, Compliance, sites, and other internal functions as needed.
• Support Global Business Owners during enhancement/change request reviews, including managing global business reviews and compiling feedback
• Ensure ongoing operational activities for the Veeva Global GxP system are aligned with global processes and standards.
• Support various Veeva Global GxP program phases with project activities as needed (e.g. data migration and cleansing, testing, etc.
• Conduct additional business training as needed post go-live to support site adoption
• Partner with appropriate functions (Business, IT) to provide issue resolution.
• Escalate issues to management as needed
• Participate in system periodic and user access reviews.
• Act as backup Global Business Owner for system validation activities for operational changes as needed (e.g. assist with gALM reviews/approvals as needed)
• Provide updates in Quality Global/regional/leadership meetings as needed.
• Any other tasks assigned by the management for smooth functioning of the team.

Qualification & Expeirnece

• 5 to 8 years of relevant experience
• Master’s degree in pharmacy or other natural sciences or bachelor’s degree in pharmacy or other natural sciences
• Good knowledge in Veeva Global GxP, QMS and EDMS processes.
• Good knowledge of Computerised Systems.
• Experienced with primary business liaisoning with IT support (FAS) for operational support activities