Job Description
Production OSD:
- Equipment Setup & Operation: Assist senior operators in setting up, assembling, and operating core granulation machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), and Co-Mills.
- Material Loading & Binder Preparation: Help load raw material APIs and excipients into processing vessels and assist in preparing binder solutions following exact BMR instructions.
- Drying & Milling Support: Monitor wet/dry granulation parameters (inlet/outlet temperatures, drying times) and operate sizing mills to achieve the required granule mesh size.
- Dry Blending & Lubrication: Load sized granules and lubricants into blenders (Octagonal, V-Blender, Bin Blender) and assist in running uniform lubrication cycles.
- Line Clearance & Area Cleaning: Perform equipment washing, drying, and room cleaning (Type A/B) during product changeovers to prevent cross-contamination.
- In-Process Testing Assistance: Help perform basic in-process checks on granules, such as Moisture Content / Loss on Drying (LOD) and bulk density tests under supervision.
- Logbook Entries: Record real-time operating parameters, room conditions, and equipment status updates in equipment logbooks adhering to ALCOA+ principles.
- Granule Storage & Staging: Transfer, label, and stage intermediate granule containers (IPC bins) into designated holding areas safely.
- Housekeeping & 5S: Maintain clean, safe, and organized processing bays in compliance with plant 5S and cGMP standards.
- Safety & PPE Compliance: Strictly follow factory EHS guidelines, wear mandatory personal protective equipment (dust masks, safety goggles, gloves), and maintain cleanroom discipline.