To approve / Reject, bulk / finished products after necessary quality review of batch manufacturing and analytical records.
To review, approve / Reject and close all change control/ deviations proposals/ records and ensure that required corrective / preventive actions are taken as identified in the concerned record.
To review, approve / Reject all master documents and report like SOP's , VMP , various validation Protocols/ Reports , Qualification Protocol/Reports, Stability Protocol etc. and retain them appropriately.
To ensure "All time Readiness" for regulatory inspections by continuous monitoring of cGMP , GLP & Regulatory Norms
To prpare, coordinate, and execute training programme schedule related to cGMP , GLP and SOP.
To ensure that sampling of intermediates/bulk/finished products/control samples and stability samples is carried out as per approved sampling plan
To investigate OOs results , Market complaints effectively and ensure that identified CAPA are put in place.
To perform Annual Product review
To improvise working as per QSG issued by CQA and various international guidelines including ICH
To perform self Inspection as per cGMP and promptly reply to all inspectional observations of Audits done by external agencies , customers and CQA