KAMBALA NARAHARA SAI
Jaggayyapet
Summary
Results-driven Mechanical Engineer with 8 years of experience in scientific equipment manufacturing and pharmaceutical operations. Expertise in Stability Chamber Qualification, Calibration, Temperature and Humidity Mapping, and Regulatory Compliance. Led efforts in supporting FDA audits and ensuring adherence to cGMP, ICH, EU Annex 11, and WHO guidelines. Proficient in installation, commissioning, maintenance, and troubleshooting of pharmaceutical systems and Environmental Monitoring Systems.
Overview
8
8
years of professional experience
Work History
Executive - QA
Suven Pharmaceuticals Limited
08.2019 - 05.2025
- Executed stability chamber qualification (IQ/OQ/PQ) and maintained comprehensive documentation.
- Calibration & validation of pharmaceutical equipment and warehouse cold storage areas.
- Developed and reviewed qualification protocols and calibration reports to ensure compliance.
- Managed Deviation, CAPA, and Change Control procedures to uphold quality standards.
- Facilitated vendor relationships to ensure timely calibration activities and maintenance contract execution.
- Supported US FDA audits for multiple units.
Service Engineer
Thermo Lab Scientific Equipment Pvt. Limited
05.2017 - 07.2019
- Troubleshooting electrical and refrigeration systems.
- Managed Annual Maintenance Contracts (AMC) to ensure compliance and operational reliability.
- Conducted temperature and humidity calibration and validation for all pharmaceutical equipment to maintain regulatory standards.
- Installation and commissioning of Stability Chambers.
- Software installation and validation (IQ/OQ/PQ).
Education
B.Tech -
Mechanical Engineering
Skills
- CGMP compliance
- FDA compliance
- Stability chamber qualification
- Temperature mapping
- Calibration & Preventive Maintenance
- CAPA management
- Environmental monitoring
- Audit support
- Vendor management
- Stability software proficiency
- Data logger expertise
- PLC Systems: Zelio, Allen Bradley, Delta
- HMI: Redlion, Monitouch
- Tools: MS Office
Languages
- Telugu
- English
- Hindi
Timeline
Executive - QA
Suven Pharmaceuticals Limited
08.2019 - 05.2025
Service Engineer
Thermo Lab Scientific Equipment Pvt. Limited
05.2017 - 07.2019
B.Tech -
Mechanical Engineering