Kalyan Kumar Thota

Experience

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  Dr. Reddy's Laboratories

  Mar 2016 - Sept 2022

  Sr.Executive

  1. Expertise in implementing standard operating procedures (SOPs) and following ALCOA principles to ensure accuracy, consistency, and completeness of manufacturing records.2. Proficient in handling Material Safety Data Sheets (MSDS) and adhering to safety protocols to ensure a safe working environment for personnel.3. Skilled in maintaining equipment calibration and conducting preventive maintenance as per SOPs to ensure quality and efficiency in the manufacturing process.4. Proven ability to coordinate and communicate effectively with cross-functional teams such as QA, QC, maintenance, and electrical departments to ensure smooth operations.5. Track record of meeting production targets and delivering high-quality products within the timeline.6. Experienced in implementing continuous improvement projects such as Kaizens to optimize the manufacturing process, increase efficiency and reduce costs.7. Committed to maintaining cleanliness and hygiene in the manufacturing facility through daily housekeeping activities.8. Proficient in handling various processes like pH adjustments, distillation, separation, filtration, extraction, crystallization, pressure reaction, and isolations.9. Experience in managing both large-scale and small-scale production of drugs. Show less

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  Sai Life Sciences Ltd

  Mar 2023 - now

  DTC and QMS

  1) Conducting risk assessments and impact assessments related to change controls, CAPA, and deviations to determine potential risks and their impact on the product, processes, or quality systems.2) Leading the initiation and management of planned changes, such as process changes, facility changes, equipment changes, and material changes, through the company's change control process.3) Reviewing proposed changes for potential quality and regulatory impacts and determining the appropriate level of review and approval required.4)Collaborating with cross-functional teams to develop risk assessments and impact assessments to evaluate the potential impact of proposed changes.5)Coordinating the execution of change controls and ensuring that all necessary documentation is completed accurately and on time.6)Managing the deviation process, including the identification, investigation, documentation, and resolution of deviations in accordance with company policies and regulatory requirements.7) Leading the root cause analysis of deviations to identify underlying causes and develop effective corrective and preventive actions (CAPAs).8)Collaborating with cross-functional teams to develop and implement process improvements to prevent the recurrence of deviations.9)Managing the equipment qualification process, including the development and execution of protocols for equipment installation, operational, and performance qualifications.10) Collaborating with cross-functional teams, such as engineering and validation, to ensure that equipment qualifications are executed in accordance with industry standards and regulatory requirements.11)Reviewing and approving equipment qualification documents and ensuring that they are completed accurately and on time.12)Developing and maintaining equipment qualification schedules and ensuring that equipment is qualified and maintained in accordance with company policies and regulatory requirements. Show less