Officer
2 weeks ago
Sr. No.Responsibilities Parenteral Packing1.0 Equipment and area qualification activity:1.1To perform the equipment qualification (SAT/ IQ/ OQ / PQ) like labelling machine, Blister machine, Cartonator machine, Track and trace system, Visual Inspection and Leak Testing Machine, Stretch Banding Machine and Weighing Balance as per VMP and approved protocol.1.2To perform the area and facility qualification for ampoule and vial line as per approved procedure.1.3To perform the visual inspectors qualification activity as per the SOP.2.0 Packing Activity:2.1To monitor the online inspection with leak test detection activity done as per the SOP.2.2To monitor the labelling and de-labelling activity done as per the SOP.2.3To monitor the packing activity done as per the SOP.2.4To perform the calibration and verification of weighing balance as per the frequency.2.5To maintain the Inward and outward record of quarantine area.2.6To monitored the Lux level of visual inspection booth as per SOP.3.0To ensure the RH, Temp. DP of the respective area within the acceptance criteria. 4.0Area and Equipment Cleaning Activity:4.1To ensure the cleaning & sanitization of controlled area as per the SOP and activity to be recorded in relevant GMP documents.4.2To ensure the cleaning & sanitization of fully automatic packaging line machines.5.0To generate the maintenance memo if any breakdown occurred in machine and also coordinate with engineering department.6.0To ensure the material movement in production areas as per the respective SOP.7.0Training and Documentation:7.1To complete the training within timeline.7.2To follow GDP while doing documentation work.7.3To update and ensure the status label (In process, Equipment, current status etc.) for area and equipment's.7.4To record the activity in respective GMP documents.7.5To filled the online documentation (BMR, BPR, Logbooks or other GMP documents) during routine activity.7.6To prepare the SOP, protocols and documents related to the production parenteral (Packing) facility.8.0To perform / involved in the area and equipment qualification and requalification activity as per the respective protocol and documents.9.0To handle and operate the computer, IPC based software system during batch processing and entering the batch activities in batch packing record (BPR) or respective formats.10.0To handle the QMS activity like deviation, change control, CAPA etc.11.0To handle manpower and work distribution as and when required.12.0To handle the packing area operations in case of power failure or AHU shutdown.13.0To ensure the daily verification or challenge test of packing equipment done before start of the activity. 14.0To execute, installation and commissioning of equipment / system.15.0To operate SAP transaction as per SOP.16.0To ensure safety during execution of project and production related activities.17.0Any other work assign by area supervisor or HOD.
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