Reviewing documentation relating to raw materials and the release of raw materials
Reviewing and Preparing batch release documentation
Reviewing and Approval of QA-controlled documentation (such as SOPs, batch records, working instructions
Authorization of all procedures and standard instructions of process, controls etc
Investigation and closure of all deviations, OOS and complaints
Conducting self inspections.
Conducting vendor evaluation of raw materials.
Should have sound knowledge of Process validation. Should be familiar with preparation of process validation protocol and report.
Should have sound knowledge of QMS System and Change Control , Deviation and CAPA Procedure.
Review of Preventive maintenance & calibration of equipment and systems.
Review of stability data to support retest or expiry dates and storage conditions and/or intermediates where appropriate.
Risk analysis evaluation
Performing product quality reviews.
Must understand standard operating procedure.