Officer, Autoclave

0 years

0 Lacs

Posted:4 weeks ago| Platform: SimplyHired logo

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Work Mode

On-site

Job Type

Full Time

Job Description

To follow the safety rules in the premises according to the company norms.
  • To maintain online the BMRs and other log books in the respective area as per cGMP and SOP.
  • Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR.
  • Responsible to perform the in process checks during operation.
  • Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and
conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air
shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder, HAWO pouch sealer.
  • Responsible for Dispensing, checking and receiving of the Raw Material from warehouse.
  • Timely completion of SOPs training and on the job trainings related to autoclave area.
••Responsible for Area cleaning and Maintain the area properly for autoclave area.
  • Responsible for operation and cleaning of dynamic pass box in autoclave area.
  • To carry out CIP & SIP of the vessels related to autoclave area.
  • Responsible for timely completion of calibrations and validations activity in coordination with Engineering
and QA related to autoclave area.
  • Responsible for operation and cleaning of area equipment present in the autoclave area like Pass boxes,
Glove cleaning and integrity testers.
  • Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the
production area.
  • Operation and cleaning of table mounted LAF and Ceiling mounted LAF and steam sterilizer and HPHV
steam sterilizer.
  • Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and
seals for sterilization as per the validated load pattern.
  • Responsible for Maintenance and cleaning of Component preparation and sterilization area (Autoclave
area).
  • To maintain the BMRs and other log books in the Component preparation and sterilization area
(Autoclave area) as per cGMP and SOP.
  • Operation and cleaning of dynamic pass box in Component preparation and sterilization area (Autoclave
area).
Cleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave area).
  • Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the
production area.
  • Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area

Qualification - B.Pharmacy, B.SC


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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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