QA

Emcure is fast-growing Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally.

Having Experience in PRODUCT, Water Testing, In process Sampling, Analysis of Bulk Water, Finished and API by MLT, Bioburden, BET, Sterility, PET and Antibiotic Assay.

Monitoring of Aseptic Area, Environmental, Media Fill, Solution Preparation, Lyophilization Operation, BFS & Infusion BAG filling. 

Production and Packing planning, Monitoring and reporting daily Production Activities, Master Creation In Pharma Cloud, SAP. IPQA, Document Issuance & Control, CSV, Stability, Validation

To Review Qualification Protocol and Reports of Equipment, Instrument, System.To Review Qualification Protocol and Reports of Computer System Validation CSV. Ensuring safe handling of Raw Materials and Packing Materials. Dispensing activity of RM and PM material.

EM, Media 111 visual inspection , Aseptic area monitoring, Water and Bioburden testing & Sterility testing & BET Testiug , IQ, OQ, PQ of equipment, Biological reactivity test - Moda exposure

Should have sound knowledge of BFS machine operation, aseptic area, maintenance, media fill, batch mfg., CIP, SIP, Autoclave, topical manufacturing. Candidate having experience in different packing lines of OSD & sterile manufacturing.

Evaluates new market complaints daily and communicates them to the various manufacturing partners, determines the criticality of complaints and makes appropriate recommendations. Escalates critical complaints and those with the potential to affect an entire batch or multiple batches. 

Should be able to develop analytical methods and perform analysis on UV, Dissolution, HPLC and ICP-OES instruments. Dissolution development, Comparative dissolution profile and multimedia dissolution study.