Responsible for effective implementation of quality assurance systems related to IPQA such as SOP review and monitoring of cGMP on shop floor and Responsible for routine IPQA activities and to ensure GMP in the Manufacturing. Responsible for review of audit observations and performing gap assessment and compliance with observations. To coordinate with R & D, QC, QA and production department to ensure smooth execution of the project. Actively involved in the scale up and validation batches along with process development department. Monitoring ongoing product in manufacturing area right from dispensing to all manufacturing. Responsible for Comply the Audit Observations by any Regulatory Agency or Customer. Responsible for handling of qualification activity related to in-process instruments. Responsible for Handling of OOS, OOT, market complaints and deviation related investigations. Responsible for handling of QMS documents (change control, deviation, CAPA and risk management). Responsible for revision of SOP as per revised guideline and audit compliance. Responsible to carry out induction training on GDP and data integrity to new employees and SOP and Calibration and operation of analytical instruments related training to existing employees. Responsible for handling of batch record related customer query. Compilation of regulatory and customer audit compliance report. Tracking of Audit related CAPA implementation and follow up from respective department. Co-ordination with respective department during the regulatory and customer audit.