Drug Product, Manufacturing - Formulation & Dispensing, Associate

DRUG PRODUCT, MANUFACTURING - FORMULATION & DISPENSING, ASSOCIATEResponsibilities:
Operation of sealing machine and 2D coding machine as per EOP.
Performing machine parts changeover of the sealing machine (according to vial and cartridge size).
Cleaning and sanitization of the machine parts of the sealing machine.
Operation of LAF in the sealing machine.
Operation and cleaning of autoclave.
Wrapping of items for autoclave.
Operation of Static Pass Box and Dynamic Pass Box.
Re-checking of Primary Packing Material (Flip Off Seal) required for the batches as per the production plan.
Checking of filled volumes as per frequency.
Operation of the weighing balance.
Operation of RABS Glove integrity tester and management of RABS Gloves.
Calibration of the weighing balance.
Monitoring and recording the area temperature, relative humidity, and differential pressure in the scaling area.
Online entry in BMR regarding sealing activities.
Timely filling of the checklist for the sealing area.
Online entry of LAF reading in the sealing area in log books as per frequency.
Ensuring fogging of the sealing area as per frequency and SOP.
Ensuring cleaning of the sealing area as well as its appropriate entry in log books.
Assisting machine trials and validation of sealing machine.
Cleaning of 2D coding machine.
Operation of the continuous sterilizing tunnel.
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