Gumpa Koteswara Rao

Experienced professional with 13+ years in pharma and biotech production, currently leading operations in formulation and filling. Skilled in batch manufacturing, equipment changeovers, and process improvements, consistently enhancing efficiency and productivity. Proven ability to manage cross-functional teams, ensuring timely project delivery and increased departmental efficiency. Deep industry knowledge and adept at implementing quality control for cost-effective product excellence.

Certificate of Appreciation, TALENT OF MONTH, 01/01/23

• Involved in green field project like qualifying vessels, micro fluidizer and bead mill.
• Monitoring Core production area of vial lines covering all activities from raw material dispensing to filling & sealing and execution of manufacturing activities as per PPIC planning.
• Preparation and review of SOP's and formats to various regulatory audits.
• Initiation & Investigation of Incidents/ Deviation Reports, breakdowns, OOLs, OOSs and OOTs related to Production operations.
• Initiation, closing and implementation of Change controls, Corrective and preventive actions & Risk Assessments related to Production operations.
• Review of batch records and GMP records.
• Responsible for safe work and environmental practices and ensuring 100% usage of PPE.
• Planning of PMP (Equipment, HVAC, utility, and validations) as per schedule.
• Responsible for BMS activities (should knowledge in operation).
• Planning of Manpower as per manufacturing schedule.
• Execution of formulation batch Calculations and operations.
• Coordination with Team members & cross functional departments for timely implementation of production schedule.
• Execution and supervision of Batch manufacturing activities filling and formulation.
• Review and submission of executed Batch records, GXP documents to QA and ensuring of compliance of executed activities.
• Training: Identification of training needs to the team members and imparting training as per monthly schedule.
• Ensuring on time completion of Changeovers of the equipment as per production schedule.
• Planning & ensuring of component/equipment preparation as per the batch schedule.
• Involvement in preparation and review of SOPs, BMRs.
• Execution of media simulations as per schedule.
• Execution of process validation batches & cleaning validation studies.
• Coordination & execution of equipment qualifications/re-qualifications.
• Supporting the filling/formulation activities in other suites as per requirement.
• Coordination & ensuring of on time completion of equipment Preventive maintenance & calibrations.
• Execution of Audit trails, System data backups and trends.
• Ensure online documentation and compliance. Supervising batches with compliance to GMP & all related SOPs.
• Write the instruction relating to production operations and ensure their strict implementation (SOPs, Batch production records, Record sheet templates, log books, etc.)
• Involved in the initial and continual training of the personnel involved in formulation and ensure their qualification as per the current standard and procedures laid down.
• Ensure the safe working and hygienic condition of the personnel working in Grade “B” aseptic areas.
• Proactively procure and ensure the availability critical consumables required for the production.
• To ensure compliance of the facility, process, personnel and documentations with cGMP all the time and make facility ready for the audit all the time.
• Ability to prepare documents (SOP’s, BMR’s, and Protocols) and giving guidance to team members in preparing documents.
• Daily reporting about the production execution, QMS system updates to the superior and Handling of QMS documents and timely closure of QMS related documents.
• Execution of EBMR through SAP postings and all transactions.

• USFDA
• NVISA (Brazil)
• TGA (AUSTRALIA)
• GERMAN
• EU

• Reading books
• Playing cricket
• Watching movies

All the details are furnished above are genuine as per my knowledge. I request you to give me an opportunity to enhance my knowledge to achieve new heights in my life.

• Being a self-starter, self-motivated, keeping focused and productive.
• Taking personal responsibility to resolve problems.
• Planning, prioritizing and organizing tasks, time management, self and team.
• Capacity to deliver positive results at high-pressure environment.
• Good interpersonal and communication skills.

• Father's Name: G. Kumaraswamy
• Date of Birth: 07/10/92
• Gender: Male
• Marital Status: Married