Technical Supervisor

To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule). To give area and machine clearance i.e. checking and approval of processing areas and Equipment's prior to start of batch processing. To verify environmental conditions i.e. Temperature, Relative Humidity & Differential Pressure conditions are within acceptable range in all areas. To perform and verify challenge tests at manufacturing and packing stages as per the pre-defined frequency. To verify the status of calibration and preventive maintenance of Equipment's used in manufacturing and packing operations. To perform sampling of In- process, finished product and retain samples as per respective MMD-I / BPR/SOP, Process validation/Hold Time/Packing Validation/Stability study as per respective protocols and to submit the samples to Quality Control for analysis. To notify the change control / Deviation related to shop floor activities. To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection and packing. Review and approval of Master MMD-I and BPR. To participate in the investigation of Deviation and Market Complaint for identification of root cause and implementation of identified CAPA. Intermediate & final Release of Finished Product in SAP. To review & impact assessment of break down intimation slip (BDIS) and to advise precautions to be taken before, during and after attending BDIS & Closure of BDIS. To ensure that batch must be manufactured and checked in compliance with laws in forced in that member state and in accordance with requirement of marketing authorization, registration dossier (ND). Any other job assigned time to time by HOD.