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