1.Operation of filling machines, sealing machines, cRABs, VHP Generators, and GLT machines.
2.Unloading of sterilized items, assembling, VHP sterilization, filling, stoppering (partial/ full), filled vials loading into lyophilizer, unloading of lyophilized vials and sealing of full stoppered vials.
3.Cleaning, inspection, integrity testing & replacement of APA RABs gloves as per frequency mentioned in respective SOPs.
4.Participation in Disinfectant filtration, APA area cleaning and documentation.
5.Participation in filtration activities and integrity testing of filters.
6.Ensuring availability of sufficient garments, shoes and Disinfectant solution.
7.Follow up and compliance to preventive maintenance of equipment and calibration of temperature gauges, pressure gauges, RTDs etc.
8.Implementation of SOPs and continuous training of workmen for cGMP compliance.
9.Online completion of GMP records in related areas.
10.Recording of physical parameters of equipment and area as per the respective SOPs.
11.Review the Temperature data printouts of holding vessels for correctness and compliance to the set parameters after completion of activity.
12.Reporting all deviations to Superiors.
13.Responsible for Evaluation of batch wise equipment related alarms.
14.Responsible to maintain the APA area to clean and control the microbial count.
15.Compliance to gowning and de-gowning procedure for entry & exit into clean rooms.
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