working in Ipca laboratory Ltd as senior officer, and my work profile is Handling of water and packing material section as a supervisor ,and also review of water analysis report and protocol report, and also prepared instrument and processing method for HPLC in Empower software, also prepared SOP and Handling QMS.
Also knowledge of Software like, Empower, Lims , Caliber Lims, EDMS, Lms, SCM, LES, Lab Solution, TOC-L,LAB-x.
o Stability, Finished, water, Packing material, raw material calibration report Review
o Review of Protocol and Report of Different Product, Investigation of Laboratory event and Out of Specification (OOS) as per GLP, Maintenance of GLP environment, SOP monitoring and revised SOP As per regulatory Guidelines
o Water Trend Prepared, Protocol and Report prepared
o Handling of Water and packing material section and release material through Lims and SCM
o Nitrogen Safety guideline Leader
o Analysis of stability sample and Finished product.
o Handling and Calibration of Instrument Like: HPLC, UV, Dissolution, Disintegration Friability
o Handling of Instrument Like: HPLC, GC,UV
o SOP, BMR, STP, Testing Protocols, Stability Study Protocol, Stability Report interval wise and Stability Summary Annexure.
o Doing all in process quality check entry in SAP.
MBA with 10 Years of Professional Experience in Quality background
Sound Knowledge on GMP Norms, ICH Quality Concepts & Quality Management systems
Exposed to Regulatory Audit Such as FDA, MHRA, ANVISA
An Effective Team Leader with Positive Coordination & Troubleshooting Skills
Working with QMS Software Like “Track wise and Documentum, LIMS,CaliberLIMS,EDMS,SCM,LES