Pharma Audit Operations Analyst (m/w/d)

Responsibilities

• As an Audit Operations Analyst (AOA) you will coordinate the audit process activities for the Quality Medicine Auditing team for all phases of audits, from planning and preparation through reporting as well as: support the lead auditor with the collection of audit relevant documentation during audit preparation accurate identification of involved local and global stakeholders as well as Suppliers, Commercial Partners, and Healthcare professionals worldwide for distribution of audit notification, plans and agendas, as well as the distribution of pre-audit document requests and after completion of the audit for distribution of audit reports liaise with local and global stakeholders as well as Suppliers, Commercial Partners, and Healthcare professionals worldwide to facilitate audit preparation document collection and management of logistics as well as to facilitate on‑time delivery of audit reports and close out activities tracking of milestone dates in the audit logistics management system as well as archive of audit relevant deliverables in the respective Document Management system
• The AOA maintains the audit systems (Veeva Vault) and electronic tools (SharePoint based) to support audit processes, standards, and communication including: acting as technical and business expert in the use of the audit systems and tools as well as ensuring the quality and completeness of entered data in all audit systems and electronic tools performing reconciliation with all audit systems and electronic tools to ensure reliability and validity of data used for performance management
• The AOA support Quality Medicine Auditing inspection readiness and inspection preparation globally and locally by ensuring ongoing archival of audit documentation in global repository and if assigned for inspection preparation activities he/she coordinates inspection related logistics as well as document retrieval from systems and archives

Qualifications

• Bachelor’s degree in Natural Sciences (e.g. Pharmaceutical)
• Fluent in English both written and spoken
• Excellent interpersonal, cultural and communication skills
• Strong analytical and organizational skills as well as strong attention to details
• Excellent IT skills, including but not limited to MS Office (Outlook, Powerpoint, Excel and Word), knowledge in Veeva Vault Audit Management would be a plus
• Ability to work independently as well as in a team