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. To assure Quality and cGMP compliance of the products being manufactured and Packed for Liquid Manufacturing Block. • To give Area /Equipment clearance i.e. checking and approval of all manufacturing & filling. To verify environmental condition i.e. Temperature, Relative Humidity & Pressure Differential condition in all for said areas are within acceptable range at all the time during operation throughout the shift. To ensure daily verification of weighing balance with standard weights. • To perform filled volume & weight method and leak test as per MMD-I & SOP. • To perform sampling of bulk and finished product for each batch at the end of the batch as per SOP entry into sampling log and submit the samples to QC for analysis. • Record review, To review the Batch Manufacturing Records for on line entries at each stage. To review sequential log of machines. To review environmental condition records. To review of area cleaning logs. • To release the batches for further processing. To review and checking Batch Manufacturing Records for reconciliation, correct entries, completeness, affixing of release status labels. • Reporting to shift in charge to address the observations under Deviations, unusual observation Daily report of total activities performed Liquid Packing : • To give line clearance i.e. checks and approval of all packing. • To perform checking and approval of overprinting details on printed packing material like blisters, cartons, labels etc. As per Batch Packing record. • To verify the correctness of primary and secondary packing materials of product being packed as per CMOF and MMD-II. • To perform periodic checks of overprinting details, number of units per pack, absence of empty pocket etc. • To perform spot-checking on inspected bottles SOP. • Record review, To review the Batch Packing Records for on line entries at packing stage. To review sequential log of machines. To review of area cleaning logs. • To co-ordinate with packing supervisor in relation to the issue related to packing. • Any job assigned time to time.
