Mokshitha Mokshitha

• Ensure the design change strategies and deliverables comply with the SOP and as per the quality standard, Projects related to supplier qualification, equipment qualification •Update risk management documents - aFMEA, and dFMEA to incorporate PMSand CER requirements and supplier pFMEA into the risk management documents to mitigate the risk. •Support in validation and verification, CAPA management activities •Support in Design change Functional impact assessment, DCN meeting and DHF closure.

• Created validation master plans, process flow diagrams, and standard operating procedures • Created templates for equipment qualification (installation, operation, and performance) protocol, plan and report, and training material for the implementation of global templates • Evaluated validation test data using Minitab • Prepared reports to summarize operational and validation performance results • Initiated CAPA and change control processes, analyzed process deviation result

• Prepared daily mixtures as per the production plan. collected and analyzed production samples to evaluate quality. • Scale-up of new products and improvement of existing production processes, creation, and maintenance of batch records, GMP documents, and standard operation procedure • Verified that raw materials, in-process samples, and finished products were as per established testing and inspection standards. • Investigated customer complaints and follow up on complaints and investigation results

• Supported production team with daily production activities • Assisted in preparing and updating and review of process documents- Batch Manufacturing Record, Equipment Cleaning Record, Standard Operation Procedure(SOP), in compliance with cGMP regulations. • Managed critical deviations, Change control, corrective action preventive action(CAPA), and audit observations and report. • Conducted periodic training for production staff • Support team in audit and inspection for audit readiness

• Supervision of Production activities, documentation of production activities SOP, BMR, ECR, change control, CAPA. • Developed operational standards and procedures for work unit and department. • Managed paper and electronic filing systems by recording information, updating paperwork, and maintaining documents- SOP, BMR, and ECR