Quality Assurance Associate
Current• Assist with the ongoing tracking and maintenance of GMP documents;• Review and maintain training records • Initiate and assist Change Control procedures and updates to Standard Operating Procedures• Assist with the maintenance of Licences (including, but not limited to: Drug Establishment Licence, Site Licence,)• Create and issue documents, logbooks and workbooks• Actively participate in internal and external audit preparations, conduct, and responses• Maintain updated Quality Agreements• Compile trending data for Quality Management meetings• Perform monthly trending of investigations, complaints, CAPAs and deviations• Keep quality assurance documentation databases in orderly and updated status• Review and approve OOS/OOT results and investigations in LIMS• Ensure compliance with GMP guidelines• Organize, update and regularly check QA documentation• Participate in determination and trending of employee’s training status including annual GMP training