- Provide remote QMS support for global sites, handling OOS, OOT, deviations, incidents and change controls.
- Review documentation for compliance & drive continuous improvement.
- Ensure timely investigation, analysis & change control initiation.
Required Candidate profile
- 9+ years of QC/QA experience in regulated pharma co.
- Reviewing OOS, OOT, APQR & lab incident investigations, change controls & managing deviations
- Solid knowledge of USFDA, EU & Health Canada