To perform QA activities at shop floor in each and every stage of sterile manufacturing and packing.
QA overview for clean room behavior and aseptic activity.
Review of batch processing records.
Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release.
Review of documents of respective areas and logbooks for adequacy and completeness.
QA overview for receipt of material from warehouse to production.
QA of Dispensing, Manufacturing, Packaging and Dispatch activities.
Review and Control of SOP's, Specification, BPR issuance, Master Formulae and Records.
Preparation & Review of process validation protocols and reports.
Executing the validation/revalidation activity in the absence of authorized person.
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