Beschreibung

In this role, you will oversee electronic documentation and records management, ensuring compliance and supporting audits. Your day-to-day responsibilities will involve managing document workflows, creating reports, and collaborating with various teams to meet documentation needs.

Anforderungen

• •High school diploma or equivalent
• •Minimum 3 years in the pharmaceutical industry with document management experience
• •On-site presence required
• •Fluent in English and German
• •Experience with Microsoft Office (Outlook, Word, Excel)
• •Previous experience in records management, data entry, or similar
• •Ability to work successfully in a team environment
• •Project Management skills
• •Strong written and verbal communication skills
• •Strong problem-solving and decision-making ability
• •Experience with documentation in a GMP environment and electronic tracking
• •Experience in quality systems such as Veeva Vault QualityDocs

Aufgaben

• •Maintain GMP Library document inventory control using the Lilly Record Manager (LRM) system
• •Create and run semi-annual reports in LRM to check inventory as a Record Administrator (RA)
• •Manage all documents and records in the Veeva Quality Docs Electronic Document Management System (EDMS)
• •Ensure compliance with global and local Documentation and Records Management requirements
• •Create, update, and route documents for review and approval in the EDMS
• •Support functions with the creation, update, routing, review, and approval of electronic documents
• •Manage and monitor assigned Veeva Vault QualityDocs workflows
• •Meet with internal personnel to review documents and assign Veeva Quality Docs metadata
• •Manage retention of GMP-related records according to Document Type and Record Class Codes (RCC)
• •Facilitate the shipment of GMP records to external storage for long-term retention as needed
• •Manage controlled print of GMP forms and facilitate the reconciliation process for executable records
• •Support external and internal audits by providing accessible records for review
• •Assist with Site Self Inspections related to Document Control and the Veeva Vault Q Docs EDMS
• •Monitor and ensure periodic reviews of documents in Veeva Vault QualityDocs are performed
• •Follow up with document owners to ensure timely review and updates
• •Collaborate with Quality, Learning and Development, and other functions to capture document needs

Tools & Technologien

Benefits