Officer Job at Amneal | BPharm/MPharm Graduates Apply Now
Amneal Pharmaceuticals is seeking an Officer, Filling to join its Production team in Hyderabad, Telangana. This Officer Job is central to aseptic processing and manufacturing, covering both Component Preparation and Sterilization (Autoclave Area) and the Filling Area. The Officer, with a B Pharma or M Pharma qualification, will be responsible for following cGMP/SOPs, maintaining online BMRs and log books, supervising Media fill and Drug products batches, and performing complex operations like CIP & SIP of vessels. The Amneal Job requires extensive hands-on experience with equipment operation, calibration, and cleaning of aseptic and sterilization equipment.
- Job Title: Officer, Filling
- Location: Hyderabad, Telangana, India
About The Company
Amneal Pharmaceuticals is a global, integrated specialty pharmaceutical company recognized as an equal opportunity employer committed to diversity and inclusion. Amneal’s manufacturing operations emphasize strict adherence to safety and cGMP standards. The Filling department, crucial for sterile manufacturing, involves extensive coordination with cross-functional teams (QA, QC, Engineering, Warehouse) to ensure the aseptic processing, sterilization (autoclaving), and cleaning (CIP/SIP) of equipment and areas meet rigorous regulatory and quality requirements.
Qualifications required for the Officer Job
Qualification – B Pharma, M Pharma
Amneal Job Job Description
- To follow the safety rules in the premises according to the company norms as part of the responsibilities of the officer job.
- To ensure aseptic area cleaning and fogging by coordinating with the engineering department as per the schedule.
- To maintain online the BMRs and other log books in the respective area as per cGMP and SOP as required in the officer role.
- Responsible for manufacturing and supervising Media fill and Drug products batches as per BMR.
- Responsible for performing the in-process checks during operation.
- Responsible for dispensing, checking, and receiving of the Raw Material from the warehouse.
- Responsible for Area cleaning and maintaining the area properly for the autoclave area.
- Responsible for the operation and cleaning of the 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) as part of officer duties.
- To maintain the BMRs and other log books in the Component preparation and sterilization area (Autoclave area) as per cGMP and SOP.
- Monitoring of DP, RH, and temperature in the compounding and filtration area, the autoclave area.
- 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 the coordination with cross-functional departments like QA, QC, warehouse, Engineering, HR, and administration for the day-to-day activities related to the officer job.
- Timely completion of SOPs training and on-the-job training related to the autoclave area and filling area.
- Responsible for the operation and cleaning of the dynamic pass box in the autoclave area and filling area.
- To carry out CIP & SIP of the vessels related to the autoclave area and filling area.
- Responsible for the timely completion of calibrations and validation activities in coordination with Engineering and QA related to the autoclave area and filling area.
- Preparation and periodic revision of SOPs related to the aseptic processing area.
- Responsible for performing the in-process checks during filling.
