Job Description
Trackwise Super User: Tracking of key performance indicators and aligning to site metrics for Quality system management (QSM) oversight of site Deviations, CAPA and Regulatory commitments
Trackwise Super User: Tracking of key performance indicators and aligning to site metrics for Quality system management (QSM) oversight of site Deviations, CAPA and Regulatory commitments
Responsibilities
Support the team for site governance forums: Management review, Quality council, Data integrity and Inspection readiness
Support the team for site governance forums: Management review, Quality council, Data integrity and Inspection readiness
- Facilitation of meetings
- Meeting minutes / KPIs / action logs
- Audit trail review of electronic logbooks
- Labware / ELN
- Support reconciliation of documents and requirements
- Reconciliation and tracking of document lists
- Development of GMP training material and best practice guides to foster Quality Culture
- Creation and management of site logbooks
- Issuance of paper logbooks
Requirements
- GMP understanding, experience in the pharmaceutical industry
- Experience in Trackwise and Labware systems
- Broad knowledge of commercial operations/quality systems
- Strong Communication skills – oral and written
- Project management skills