Senior Executive, Autoclave

Amneal Pharmaceuticals LLC; Hyderabad; On-site; INR 350,000 - 520,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a hands-on operator for the Component Preparation and Sterilization area (Autoclave area). You will monitor DP, RH and temperature, and perform equipment maintenance in this zone to ensure compliant production.

You will maintain BMRs and logbooks as per cGMP and SOP, operate and clean dynamic pass boxes, sanitize drain points, prepare, filter and issue disinfectants, and coordinate with QA, QC, warehouse, HR and other functions for day-to-day activities.

Responsibilities

• Monitoring of DP, RH and temperature in Component preparation and sterilization area (Autoclave area).
• Maintenance and cleaning of Component preparation and sterilization area (Autoclave area).
• Maintain BMRs and other logbooks in Component preparation and sterilization 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 solution to all sections in the production area.
• Operation and cleaning of glove and filters integrity testers
• Cleaning and storage of all filling machine accessories and change parts.
• Operation and cleaning of table mounted LAF and Ceiling mounted LAF.
• Operation and cleaning of 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.
• Coordination with cross-functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities.
• Timely completion of calibrations and validations in coordination with Eng and QA related to Component preparation and sterilization area.
• Timely completion of SOPs training and on-the-job trainings related to Component preparation and sterilization area.

Job description

To follow the safety rules in the premises according to the company norms.

• MonitoringofDP,RHandtemperatureintheirComponentpreparationandsterilizationarea(Autoclave area).
• ResponsibleforMaintenanceandcleaningofComponentpreparationandsterilizationarea(Autoclave area).
• TomaintaintheBMRsandotherlogbooksintheComponentpreparationandsterilizationarea (Autoclave area) as per cGMP and SOP.
• OperationandcleaningofdynamicpassboxinComponentpreparationandsterilizationarea(Autoclave area).
• CleaningandsanitizationofdrainpointsinComponentpreparationandsterilizationarea(Autoclave area).
• Preparation,filtrationandissuanceofdisinfectantanddeactivationsolutionstoallthesectionsinthe production area.
• Operation and cleaning of glove and filters integrity testers
• Responsible for cleaning and storage of all the filling machine accessories and change parts.
• Operation and cleaning of table mounted LAF and Ceiling mounted LAF.
• Operation and cleaning of steam sterilizer and HPHV steam sterilizer.
• PreparationofloadsmeantforAutoclavinglikegarments,disinfectant,filling,filtration,rubberstopperand seals for sterilization as per the validated load pattern.
• Responsiblefortheco-ordinationwithcrossfunctionaldepartmentslikeQA,QC,warehouseEngineering, HR and administration for the day to day activities.
• ResponsiblefortimelycompletionofcalibrationsandvalidationsincoordinationwithEng.andQArelated to Component preparation and sterilization area (Autoclave area).
• TimelycompletionofSOPstrainingandonthejobtrainingsrelatedtoComponentpreparationand sterilization area (Autoclave area).