To provide support to the global network of VQMS User Communities with standard activities to ensure business continuity and efficient system usage, including, user issue resolution, reporting from VQMS, training, communications and supporting business change management.
The purpose of the role is to support effective data management and alignment between VQMS and associated applications including, but not limited to, Code Orange, Formatted Output Reports and interfaces.
Key Responsibilities
• Manage VQMS Searching, Reporting and Dashboards providing user support/training, maintenance of existing and creation of recent as .
• Single Point of Contact for inspection support regarding reporting from VQMS.
• Own the VQMS Formatted Output Reports and ensure they remain aligned to business processes.
• VQMS Business Lead for the alignment between VQMS and Code Orange working in close partnership with Business Leads and Code Orange Technical Leads.
• Drive Standard Work Activities for VQMS including data changes (List of Value; Bulk data changes), access management,
External Auditee review and approval, and general user support/issue resolution and action of the VQMS Mailbox.
• Drive the VQMS Access Review Process.
• Drive rapid resolution of issues escalated from the VQMS User Community.
• Complete ALM testing to support VQMS configuration releases.
Experience Required
• Minimum Batchelor Degree in Science or Business Administration or able to demonstrate equivalent level of knowledge/experience.
• Global applications, Quality processes and data reporting to support a global network of customers on an enterprise application.
• Experience in pharmaceutical/biological manufacturing or other highly regulated environments to understand the required compliance aspects.
Skills
Data Integrity, Data Quality, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Qualit