In process Quality Assurance -
Responsible for GMP aspects on shop floor, Handling/evaluation of incidents, deviations and change controls. Initiating team building and improving the performance of the team with quality orientation.
Evaluating the control process parameter and triggering the process validation, execution of process validation and maintaining the records. Also handling of regulatory queries/variation filing.
Quality Management System
Handling/evaluating of deviations, change controls and CAPA with thorough investigation. Handling of site master file preparation/revision, Quality manual preparation / revision, Validation master plan preparation/revisions. Handling of Document control systems.
Key role in handling of market complaints with implementation of mitigation measures to avoid the same complaints in future.
Triggering and implementing the corrective and preventive action by studying the deviation, Market complaints, Incidents etc.
Assessing changes in cleaning procedures/equipment/cleaning agents/change in process/new molecule and execute the cleaning validation with maintaining the documents such as matrix/protocols/reports. Handling of queries related to the same.
Quality risk management
Key role in preparation of the QRMs, evaluation of the risk to quality based on scientific knowledge and ultimately linking to the protection of the patient. Responsible for coordinating quality risk management across various functions and departments.