- To review the analytical reports for GMP compliance as well as technically, review the related OOS, OOT, Notification, and Deviation to close the same or implement the CAPA.- To review various documents like standard operating procedures, formats validation/stability protocols, validation reports, specifications, method of analysis, analytical reports etc. For the analytical support to qa, analytical laboratory and product evolution and analytical support laboratories including LIMS review. - To review the CCF and check the related documents and doing the impact analysis for the change give the suggestion.Preparation and review of Trending of RM, IN-Process, FP, Stability using “MINITAB” software, To check the product trend and product behaviour, after hundred batches of product decided the upper control limit and lower control limit.- To review of process validation protocol and report , method validation protocol and report , Cleaning validation protocol and report- To lead a team of stability person, giving guidance to solve the problems , management of stability chamber in the sense to maintenance of stability chamber sample keeping for stability and withdrawal of sample, protocol preparation for the stability sample, photo stability protocol etc.

- To responsible for all activities in the QA, including cGMP/cGLP/cGXP, documentation and implementation of departmental quality systems.- To ensure the general day to day functioning of the quality assurance.- Documentation control ensuring archival/retrieval and updation of documentation as per regulatory compliance.- Responsible for interdepartmental coordination for execution of CAPAs.- Responsible for management of deviations, change control and OOS of site.- Responsible for execution of training of QA personnel as per yearly training schedule.- Ability to handle market complaints, change controls, deviations, OOS, Failure Investigation, Art work.- Responsible for method validation, Process validation and cleaning validation.- Responsible for the DQ, FAT, SAT, IQ ,OQ ,PQ for the new equipments .- Responsible for re-evolution of equipment requalification for existing one as per the internal system.

Analytical work , sampling of starting material , in process and FP etc.