Helping manage remediation efforts, CAPA projects, and audit back room activities
- Assisted large orthopedic medical device manufacturer with multi-functional FDA warning letter response remediation effort as project manager reporting to project leads. Prepared schedules, led team meetings, prepared minutes with action items, created metrics and reports. Efforts focused on process validation, MDR, gages, purchasing and CAPA. Prepared slides for and attended weekly executive management review of the remediation effort.
- Supported back room for remediation team during 21 day FDA audit, kept CAPA document log, ensured prompt delivery of documents, supported general document tracking, followed up with team members for completion of outstanding audit tasks, facilitated communication between back rooms.
- Supported CAPA team, assisted CAPA owners with creation of schedules, team meeting minutes and presentations. Created metrics and reporting formats, followed up with CAPA owners to progress CAPAs, assisted management and director with CAPA group strategy, created weekly executive and monthly divisional CAPA review metrics and presentations. Assisted in project management of corporate CAPA activities, budgets and presentations.
- Managed deviation back log reduction team to meet FDA deadlines at multi-national pharmaceutical company
- Managed serialization project at multi-national generic pharmaceutical company
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