To ensure Current Good Manufacturing Practices (cGMP).
Self-inspection audits at plant, to ensure compliance to lay down systems.
To ensure that appropriate in-process Controls/ Online checking is being performed during manufacturing and packaging operations.
Investigation of various market complaints received and to ensure compliance to the corrective actions mentioned in art of specifications Investigation.
Analyzing the Incidents / OOS in the plants and resolving them scientifically and logically.
To ensure that quality system, process and procedure are in compliance with all regulatory requirements.
To review and track the product related Deviations and Change Controls so as to evaluate nonimpact of it on validated processes and Regulatory filing.
To ensure compliance to Good Laboratory Practices (GLP) and Current Good Manufacturing Practice
To ensure that Raw Material (RM), Packing Material (PM), In-process Goods, Finished product (FP) is being tested as per approved Standard Testing Procedures (STP) and are released.
To Review of the batch records. Review of testing records & COAs.
Co-ordinate & ensure availability of current versions of Batch Manufacturing Records (BMR)/ Standard Testing Procedures (STP)/ Specs & for preparation of APR.
To ensure testing of stability samples is being done as per approved protocol/ Standard Testing Procedures (STP).
To review the stability test reports and highlight the problems observed to the Management.
To ensure that Equipments & Processes employed in the manufacturing /Testing are qualified and validated.
To review Qualification/Validation reports & participate in validation activity whenever necessary lead Validation team.
Review and updating Site master file, Quality manual, layout, Validation master plan, Process validation
protocol, Process validation report, Batch Manufacturing Record, Corrective and Preventive Action (CAPA), Media fill protocol Investigation of customer complaint and other incident related to quality. Review of compliance report to be submitted to regulatory authority.
Monitoring of the yields and losses at all critical stages.