Manage the batch release team to ensure timely release of all bulk and packaged stock according to cGMP. oCompile and verify release documentation.oNotify management of any release delays.oConfirm completion of deviations, OOS, and specifications.oMaintain retention rooms and batch record files.oCheck accuracy of lab reports and ensure inclusion.oVerify yield calculations and compliance.oInspect retention samples for quality.oReport non-conformances to the QA Manager.
Quality Management System
Coordinate and document deviations, Food Safety Incidents and CAPAs.oAssist with SOP reviews and updates.oConduct AQL checks where required.oAssist with internal and external audits.oAssist with customer complaints investigations.oEnsure the batch release team is adequately trained.oAssist with the approval of Master batch manufacturing records, material specifications and Yield Investigation Reports.oAssist with the review of general Quality Management System activities.