Review of BPR, batch cleaning record, test data sheet, Sampling of API finished goods. Preparation of APQR. Handing of QMS document Change control, Deviation, CAPA, OOS, OOT review.
Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP. Ready to work in rotational shift.
Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares
Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.
Candidate should have experience in IPQA activities for Manufacturing. Packing area and Warehouse for Sterile Facility. Candidate should have experience in Sterile facility and good competency require in Qualification & Validation activities