Reviews and approves the executed batch records pertaining to the preparation, formulation, granulation, compressing, coating and printing or any additional stage of the final dosage form of all products manufactured.
Evaluate quality incidents and generate process events during production orders.
Review detected incidents or deviation in Trackwise system during.
Performs audits of the manufacturing rooms to assure that are in compliance with the requirements established.
Opens notice of event (NOE) in the TrackWise system for any detected incident, deviation or documentation error during the batch record review process.
Assures that Quality Events (QE) are completed within the time frame provided in site procedure. If time extension is required, assure timely submission of required documentation.
Review and approve samples of eLims.
Audit the process in Epes and SAP.