Job Description

To perform the in process checks for control on production for the process / product being manufactured. To ensure Quality and cGMP compliance of the products being manufactured. Parenteral Manufacturing : o 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 ensure sterilization cycles completion as per loading pattern & SOP. To ensure lyophilization cycles completion as per MMD-I & SOP. o To perform filled volume & weight method and leak test as per MMD-I & SOP. o 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. o 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. o To release the batches for further processing. o To review and checking Batch Manufacturing Records for reconciliation, correct entries, completeness, affixing of release status labels. o Reporting to shift in charge to address the observations under Deviations, unusual observation Daily report of total activities performed Parenteral Packing : o To give line clearance i.e. checks and approval of all packing. o To perform checking and approval of overprinting details on printed packing material like blisters, cartons, labels etc. As per Batch Packing record. o To verify the correctness of primary and secondary packing materials of product being packed as per CMOF and MMD-II. o To perform periodic checks of overprinting details, number of units per pack, absence of empty pocket etc. o To perform spot-checking on inspected ampoules/ vials SOP. o To verify challenge test for brevity inspection machine. o 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. o To co-ordinate with packing supervisor in relation to the issue related to packing. o Any job assigned time to time.

Skills Required