To assure Quality and cGMP compliance of the products being manufactured and Packed for Cephalosporin Block. • To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing. • To ensure IPQA functions and periodical verification of in- process parameter as per batch record and SOP. • 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. • Ensure timely review of executed batch processing record and stage clearance for further activity. • Review and approval of Master MMD-I & Batch packing record • To deliver the training for IPQA/Shop floor Team as per schedule and as when required. • To participate in Regulatory/Internal Audit and cGMP review meeting and facilitate its compliance. • Preparation, review and approval of SOP and ensure proper implementation at shop floor. • Intermediate & final Release of Finished Product in SAP. • To assess the impact of Incident, Deviation, Change Control and CAPA. • To participate in investigation of cGMP non conformances, Deviation, Market complaints and Incident for identification of root cause and implementation of identified CAPA. • 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.
