Goutham Kumar Namavarapu

Experience

• 

  Dr. Reddy's Laboratories

  May 2012 - Mar 2017

  Sr. Team Member

  • Assess and approve Electronic Master Batch Records (eMBR) and Executed Batch Records (eBR) within the scope of the MES-PAS|X application.• Strategize and meticulously monitor Qualification and Validation activities of Production.• Review and approve Qualification Protocols (IQ, OQ, PQ) and Reports for Production Equipment Qualification and Validations (CSV) within MES-PAS|X clients.• Maintain GxP compliance and lead the investigation into system non-conformities.• Conduct detailed reviews of department Standard Operating Procedures (SOPs).• Participate actively in Quality Risk Management (QRM) and assist in implementing effective mitigation strategies.• Function as the Administrator for the Training application - LMS. Show less

• 

  Granules India Limited

  Apr 2017 - May 2019

  Executive

  • Developing and tracking production output plans on a daily, weekly, and monthly basis.• Using IT Application tools, specifically the Batch Information Management System (BIMS), for an in-depth review of Master Batch Records (MBR).• Carrying out detailed reviews of department Standard Operating Procedures (SOPs).• Leading the efforts to ensure GxP Compliance and implement the QMS.• Designing and delivering GxP trainings through digital tools, such as Training application (LMS)

• 

  MSN Laboratories

  Jun 2019 - May 2020

  Shift Incharge

  • Schedule and monitor validation activities on the Production Floor efficiently.• Responsible for drafting User Requirement Specifications (URS) and play a significant role in reviewing and authorizing Protocols (IQ, OQ, PQ) and Reports for Validations (CSV).• Core Team Member (CTM) in the development and validation of essential IT applications such as “DMS” and “BIMS”.• Perform a thorough review of SOPs and manage the Quality Management System.• Spearhead Quality Risk Management (QRM) initiatives, actively involved in reviewing mitigation strategies to ensure the strength of processes and systems. Show less

• 

  HETERO LABS LIMITED - India

  Jun 2020 - now

  • Leading the digital operations on the shop floor through the use of Manufacturing Execution System (MES), QAMS, ELMS, SAP and other tools.• Performing comprehensive reviews of User Requirements (URS), Risk, and GxP Assessment.• Efficiently overseeing project timelines and tracking progress, while preparing detailed Project Reports for management review.• Evaluating and approving the Qualification strategy and related deliverables (such as FRS, DQ, VP, RTM, IQ, OQ, PQ, VSR, SOPs) for Computerized System Validation (CSV).• Developing and implementing remediation plans for legacy systems to ensure they meet Regulatory requirements.• Ensuring IT Compliance for production systems in line with 21 CFR, EU, & GAMP regulations.• Supervising activities related to the Quality Management System (QMS), including Change controls, Deviations, Investigations, CAPA, and conducting Quality Risk Assessments.• Conducting GxP Trainings using digital tools to improve efficiency and effectiveness. Show less • Leading the digital operations on the shop floor through the use of Manufacturing Execution System (MES), QAMS, ELMS, SAP and other tools.• Performing comprehensive reviews of User Requirements (URS), Risk, and GxP Assessment.• Efficiently overseeing project timelines and tracking progress, while preparing detailed Project Reports for management review.• Evaluating and approving the Qualification strategy and related deliverables (such as FRS, DQ, VP, RTM, IQ, OQ, PQ, VSR, SOPs) for Computerized System Validation (CSV).• Developing and implementing remediation plans for legacy systems to ensure they meet Regulatory requirements.• Ensuring IT Compliance for production systems in line with 21 CFR, EU, & GAMP regulations.• Supervising activities related to the Quality Management System (QMS), including Change controls, Deviations, Investigations, CAPA, and conducting Quality Risk Assessments.• Conducting GxP Trainings using digital tools to improve efficiency and effectiveness. Show less

  • Deputy Manager

    Apr 2022 - now

  • Assistant Manager

    Jun 2020 - Mar 2022