5+

Fermentation Microbial, mammalian, Proficiency in aseptic technique, exposure to Centrifugation, TFF, Homogenization operation, Filter integrity testing, CGMP, Autoclave operation, media preparation

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.

B.Pharm/M.Pharm/B.Sc/M.Sc; Production and Packaging, Planning, Monitoring and Reporting production activities. Purchase and procurement planning, monitoring and reporting purchase activities

Collecting and submitting in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples as per the respective procedures, batch manufacturing records and packing records, protocols. Conducting AQl inspections and periodic inspections of control samples

B.Pharm / M. Sc; Handling the Lab instruments of HPLC, Dissolution, D. T., Apparatus, Weighting Balance, Friability, Hardness Tester, FTIR, UV-Spectrophotometer. Analysis of Raw Material, In-process, Finish Products, Stability Tastings, Process Validation, Participate in Lab incident/OOS/OOT/Analytical Deviation.

Candidate should have strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Monitoring critical process parameters during manufacturing. Candidate should have sound knowledge of QMS - Incidents, Change control, Deviations etc. Should be able to handle the team of 8-10 persons

Planning and performance of Validation, Verification of analytical methods as per the relevant procedures, protocols. Experience in Handling of GC, HPLC, IC, UV instruments with Lab solutions, Empower, Chromelon, Magic net software and experience on LIMS.

Compression, Coating, Capsule Filling, FBP. QC Microbiology, IP/FP, Stability, GLP,RM. QA IPQA, AQA, APQR.