IPQA, Compliance, Cleaning Validation, Process Validation, Qualification, QMS

To perform the line clearance of manufacturing area and equipments.To participate in batch manufacturing activitiesTo review and execute batch manufacturing records.To review SOPs as per current regulatory requirement.To look after compliance of dispensing, manufacturing, sterile filling & Sealing, autoclave area, external vial washing and visual inspection of filled and sealed vialsTo involve and execute Media fill simulation.Responsible for overall compliance of sterile processing activities in shopfloorTo ensure issuance of material as per pre-approved BOM.To perform In process sampling of semi-finished and finished goods sampling.To take part in execution of cleaning validation.To prepare SOPs.To impart a training of SOPs and Protocols.Reserve samples management.Change control management.Deviation handling.To review CAPA and to perform effectiveness checksTo take part in execution of equipment qualifications.To release the batchTo perform the Audit in different areas.

To perform the line clearance of manufacturing area and equipments.To participate in dispensing activityTo participate in batch manufacturing activitiesTo participate in execution of batch filling activities and in process samplingTo perform SAP transactionTo participate in Media fill activitiesTo review executed batch manufacturing recordsTo release the batch

To prepare and review batch manufacturing recordsTo review QMS documents like change control, Deviation, CAPATo comply in process activities performed during manufacturing

Autoclave preparationTo perform filling activities of sterile vials BMR executionInvolved in preventing break downEnsuring compliance of sterile facilityTo prepare change controlTo prepare deviation