Madhusudhan Rao Aduri

To be part of challenging projects and to achieve career goals in synchronization with organization goals. To achieve challenging and responsible position in the area of Pharmaceutical Quality Assurance in pharmaceutical Industry that fosters creativity and innovation through trust, flexibility and freedom to work towards organizational goals for a Quality Product and benefits coupled with career orientations

Core Competencies: Actively involved in new facility and equipment qualification Actively involved in production equipment qualification Actively involved in BMS (radix) qualification for the new facility Involved in Process simulation (media fill) SOP Management Involved in Quality Management System (QMS) Involved in the production activities Preparation of BMR's, BPR's & SOP's. Handling of process activities. Work allocation to the man power. Qualification of equipments and systems (HVAC & PW & WFI generation and distribution systems) Qualification of different types of Equipment and Responsibilities Steam sterilizers (Pharmalab, Machine fabrik) Depyrogenation tunnel (Sterline, Romaco & NKP pharma) Compounding System & Mixing Vessels (Adem fabri works, Vynkateshan fabrications) Vial washing machine (Sterline, Ambica & NKP pharma) Vial filling machine (Romaco & NKP pharma (Dry powder injectable), Steriline and Trucking (Liquid injectable) Vial Sealing machine (Romaco and NK pharma) Lyophilizers (Tofflon, Truking & IMA) Cold chambers, Deep freezers, and walkin in chambers (newtronic) and walk in incubators Temperature mapping of ware house Temperature and RH mapping of material storage rooms as part of seasonal qualification Preparation of protocol like Installation qualification, operational qualification and performance qualification for different types of equipments like Autoclaves, Vial washing machine, Depyrogenation tunnels, Filling machines, Lyophilizers, Automatic Loading and unloading systems, Sealing machines, Automatic Inspection machine and packing equipments. Execution of qualification protocols Compilation of executed data Preparation of summary reports Execution of periodic validations as per validation master plan Compilation and documentation of equipment qualifications (URS, DQ, FAT, IQ, OQ & PQ) Reviewing of the analytical reports of water (PW, WFI and PSG) Development of testing methods for qualification of equipments Involved in the FAT for entire filling line equipments at NKP pharma. In-process Quality Assurance Responsibilities: Responsible for giving Line clearance for compounding, autoclaves, filtration, Decartoning of vials, vial washing, filling and sealing activities. Monitoring of NVPC. Checking of all log books with respect to SOP's for completeness and correctness Monitoring of media fills and preparation of final report. Monitoring of environmental results. To guide the operator / supervisor regarding any deviation observed during the process Sampling and testing of in-process materials and drug products Review of executed BMR's and their related attachments for completeness. Responsible for compliance to cGMP. Review and verification of SOPs related to specified area. Ensure the Temperature and Differatial pressure are within the aceeptance limit. Ensure measured values obtained from persons (ex: Timings, entries etc.) Production Responsibilities: Responsible for handling of production activities like Autoclave, compounding, filtration, filling and sealing activities. Checking of all log books with respect to SOP's for completeness and correctness Handling of man power during activity. Preparation of shift schedules and planning of activities as per the production plan. Work allocation to the personnel as per the production plan. Preparation of refreshment training schedules and cGMP training schedules. Preparation of BMR's, BPR's in DMS. Handling of process related change controls, incidents & deviations. Responsible for the closure of process related QMS tools. Responsible for completeness and correctness of documents in the process area. Coordinating with cross functional teams during audit response. Responsible for Handling and implementation of the Quality Management System effectively. Responsible for review the reports of incidents, deviations and change controls prior to close by QA Head. Responsible for Handling of change controls, incidents, deviations related to all departments. Responsible for handling and implementation of CAPA effectively. Responsible for the preparation and review of all types of documents. Responsible for the handling and compilation of internal audit reports. Coordinate with managers during preparation of vendor audit plan. Conducting, Compiling and filing of the management review meeting data. Responsible for conducting trainings to all employees. Responsible for review of all types of documents. Monitoring and maintaining GMP in shop floor.

• Masters in Pharmacy, Acharya Nagarjuna University, Guntur
• B.Pharmacy, Kakatiya University, Warangal

• Regulatory Audits: USFDA, MHRA, ANVESA & WHO.
• Customer Audits: SANDOZ, Mylan, Fresinius Kabi, Eli Lilly, Dr. Reddy's, Cipla Limited, Hospira, Pfizer, Sagent Pharmaceuticals Inc.

• Actively involved in new facility and equipment qualification
• Actively involved in production equipment qualification
• Actively involved in BMS (radix) qualification for the new facility
• Involved in Process simulation (media fill)
• SOP Management
• Involved in Quality Management System (QMS)
• Involved in the production activities
• Preparation of BMR's, BPR's & SOP's.
• Handling of process activities.
• Work allocation to the man power.
• Qualification of equipments and systems (HVAC & PW & WFI generation and distribution systems)

I hereby declare that the above written particulars are best of my knowledge and belief.