Officer

Responsibilities

• To give Line clearance for area and equipment for dispensing, batch manufacturing, filling and packing activities.
• To perform the in-process checks at shop floor as per written procedure.
• Sampling and TDS printing of in-process / validation / SFG / FG / Cleaning samples as per approved Batch Production Record/Protocol/SOP and timely submission of the samples to QC.
• To review and approval of process order for BPR printing.
• To ensure the manufacturing and packing operation are carried out as per approved Batch Production Record/SOP/Protocol.
• To ensure compliance to the standards established for Manufacturing compliance and Warehouse compliance in Inhaler Facility.
• To perform activities in SAP like Process order approval for BPR printing, Reprinting of additional page, Approval of material return note & additional material issuance approval, Attachment of inspection plant to inspection lot/Release of inspection lot of SFG, Physical sampling confirmation, Test Data Sheet Printing, Printing of SOP formats, Approval for the reprinting of SOP formats, Reconciliation of SOP format printed.
• Analyse the gap between the actual practices at Shop Floor against the written procedures (SOPs) and to bridge the gaps.
• To Co-ordinate with QC to get the result for further operation.
• To review the filled batch records.
• To ensure training completion of self within the defined time period that are part of TNI and to ensure c-GMP and GxP training completion as per the schedule.
• Responsible to perform job assigned by superiors from time to time.

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