Senior Quality Analyst
Octapharma AG
12.2019 - Current
- Improved product quality by implementing clear procedures for the management of the quality document system and identifying areas for improvement.
- Lead the Corporate team supporting the readiness and formal qualifications for 9 local sites and managed the successful execution of migrating documents into the Quality EDMS, delivered on schedule.
- Successfully delivered Release 2 of the Quality EDMS system through collaboration with Development teams to establish performance baselines for the system, setting high standards that guided ongoing QA efforts from inception through release.
- Took on the role of Validation Manager for formal Operational Qualification and Performance Qualification.
- Main responsibilities: Deputy System Owner within the Business Applications team, reporting to the Quality Business Partner, Risk Analysis, Periodic Review for the Quality EDMS system to ensure compliance with GxP
- Communicated between product owners and developers to clarify features.