•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.
•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 Dispensing, checking and receiving of the Raw Material from warehouse.
•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 operation and cleaning of dynamic pass box in autoclave area.
•To carry out CIP & SIP of the vessels 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).
•Cleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave
area).
•Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area.
•Responsible for timely completion of calibrations and validations activity in coordination with Engineering
and QA related to autoclave area.
•Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering,
HR and administration for the day to day activities.
•Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by
following HODs instructions and guidance.
Education:
Experience:
Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
