Atmakuru Venkata Suman

To effectively manage the team's activities and priorities in a structured and organized way, ensuring timely completion of objectives related to environmental monitoring. • Plan and Schedule microbiology related project activities ensuring project timelines related testing activities for drug substance & product including Sterility testing, Endotoxin testing (Gel clot, Kinetic & chromogenic method), Bioburden & contamination check in laboratory information management system (LIMS). • Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Validation & Project management, to ensure timely completion of the testing activities with GMP standards. • To Communicate the project status, risk associated with the testing, immediate discussion with stakeholders and leadership in clear and concise manner with minutes of meeting. • Conduct investigations of out-of-specification (OOS) & out of Trend results, deviation, media fill failure, product failure for root cause analysis and to implement appropriate corrective and preventive actions (CAPA). • To strengthen process effectiveness and continuously improve established procedures, Gemba walks will be conducted at regular intervals, with corrective actions taken in accordance with QMS standards. • Quality Management Systems QMS: Ability to implement and maintain effective QMS to support continuous improvement, Good documentation practices & data integrity principles (ALCOA+) during microbiological testing. • Data Analysis and Metrics: Analyzing data to monitor driven decisions for improvement. • Leadership and Team Management: Inspiring and guiding a team to achieve quality goals and fostering a culture of quality Change management Deviation management Risk assessment & Root cause analysis Inspection readiness Languages English Telugu Kannada Hindi Personal Details Date of Birth: 29th May 1986 Nationality: Indian Marital Status: Married Gender: Male Education details M. Sc: Micrbiology Gulbarga University B.Sc: Biotechnology Gulbarga University Audit Faced: • USFDA • ANVISA • FIMEA • MHRA • TGA • Health Canada consciousness. • Change Management: Managing changes in processes, technology, or regulations while ensuring the quality. • Deviation management: responsible to identify, document, investigate from established procedures or specifications to enhance efficiency and quality. • Risk Management: To Assess project risks, establish action logs, and implement mitigation strategies to address potential issues in processes and products, ensuring the prevention of quality concerns, • Audit Management: Responsible for any time audit readiness, self-inspection audit schedule and Response to the audit observation. • Training management: The Team members were under continuously engaged to trained, mentored on the QMS elements, Growth opportunities which were driven to achieve high quality standard of the work. • Involved in planning of Microbiological validations and ensuring the execution of the same. • Prepared/reviewed SOP's, standard testing procedures, protocols, reports and risk assessments. • To prepare and implementation of Annual Calibration Calendar for laboratory equipment's

Expertise in microbiology laboratory instruments/equipment validations/Qualification. • Participate in self-inspection as part of compliance verification and ensure necessary corrective and preventive action. • To Ensure the timely completeness of the preventive maintenance, calibration, laboratory maintenance and breakdown maintenance of the instruments/equipment's in microbiology laboratory. • To Initiate, review and implementation of the change controls, CAPA, Deviations, protocols, report and SOP's. • Facilitate/ participate in the execution of the protocols in compliance to the requirements as defined in protocols. • To facilitate the daily monitoring of the temperature, differential pressure, humidity and cleanliness of the Microbiology laboratory. • Uganda • SAHPRA (South Africa) • SFDA (Saudi Arabia) • Kenya • Co-ordinate/ facilitate and conduct training as per the schedule/ requirement. • Preparation of the user requirement specification (URS) for the new equipment's and software application related to microbiology Department. • Decommissioning of the Instruments/ equipment's which are not operatable conditions. • Commissioning of the new Instrument / Equipment's as per the requirement of the Microbiology laboratory. • Facilitate / Perform the Re-qualification of the equipment's in the Microbiology laboratory.

Well versed with Quality management system for Deviation management, CAPA management & Change management. • Preparation of the user requirement specification (URS) for the new area qualification, equipment's and software application related to microbiology Department. • Change initiation, document preparations related to area qualifications, equipment qualification and computer system validation related activities of microbiology department. • Quality risk management (QRM) preparation for the area qualification, equipment qualification, Facility modification, Vendor qualification related to microbiology department. • Designing of the recipe & loads, load development and qualification for the steam sterilizer, Isolator & Incubator. • Responsible to identify the continuous improvement projects with the procedure and simplification of the procedures. • Handling of the training related activities - preparation of the training risk assessment, design of the curricula, preparation of the training questionnaire. • Responsible for assistance for internal, external (Regulatory) and vendor related audits.

Responsible for procurement, management of inventory in microbiology laboratory. • Responsible to perform environmental monitoring program in microbiology and Production area. • Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation. • Responsible to provide the training on the Aseptic techniques & Process simulation activity. • Responsible to prepare the trend analysis for environmental monitoring & Water analysis. • Responsible for preparation of the media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories. • Responsible to perform the miscellaneous studies related to microbiology laboratory department. • Responsible to perform Bacterial endotoxin test, LBPC Analysis, BI Enumeration and CCIT. • Responsible to initiate, review, assessment and closure of change control related to Microbiology laboratory.Sterility testing and method validations.

Responsible for procurement, management of inventory in microbiology laboratory. • Responsible to perform environmental monitoring program in microbiology and Production area. • Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation. • Responsible to provide the training on the Aseptic techniques & Process simulation activity. • Responsible to prepare the trend analysis for environmental monitoring & Water analysis. • Responsible for preparation of the media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories. • Responsible to perform the miscellaneous studies related to microbiology laboratory department. • Responsible to perform Bacterial endotoxin test, LBPC Analysis, BI Enumeration and CCIT. • Responsible to initiate, review, assessment and closure of change control related to Microbiology laboratory.Sterility testing

Responsible for procurement, management of inventory in microbiology laboratory. • Responsible to perform environmental monitoring program in microbiology and Production area. • Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation. • Responsible to provide the training on the Aseptic techniques & Process simulation activity. • Responsible to prepare the trend analysis for environmental monitoring & Water analysis. • Responsible for preparation of the media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories. • Responsible to perform the miscellaneous studies related to microbiology laboratory department. • Responsible to perform Bacterial endotoxin test, LBPC Analysis, BI Enumeration and CCIT. • Responsible to initiate, review, assessment and closure of change control related to Microbiology laboratory.

Responsible to perform the Microbial enumeration test for Raw material, In-process and finished product. • Responsible to perform environmental microbial monitoring in Aseptic manufacturing area, clean room qualification, documentation and Trending Analysis. • Responsible to performed bacterial endotoxin test for Water, Raw Material and Finished Products. • Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation.