Gowri Satya Bhaskar Nandigam
Production Specialist
Hyderabad
Summary
Proven Production Specialist with a robust background at Dr. Reddy's Laboratories, excelling in manufacturing operations and process compliance. Demonstrated expertise in upstream processes and analytical equipment qualification, enhancing workflow management through effective collaboration and documentation. Skilled in navigating audits and implementing process improvements, showcasing a commitment to quality and efficiency.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Production Specialist
Dr Reddys Laboratories
2022.08 - Current
- Planning and execution of daily batch activities.
- Well versed with upstream process with expertise in ATF(perfusion) system.
- Preparation of DFM,MFR,BMR,SOP and deviation reports.
- Collaboration with QA, QMS, MS&T and R&D to execute process validation batches.
- Logging and investigation of deviations through SAP and DCMS.
- Coordination with external vendors to implement alternate materials and performing their QRA
- Involved in qualification of analytical equipments and SUB right from URS preparation to ERN.
- Audit readiness and faced MHRA, USFDA and internal GQA audits.
Technical Trainee
Dr Reddys Laboratories
2021.08 - 2022.07
- Learnt key aspects cGMP, GDP and GLP.
- Actively involved in data collection and interpretation using graphs to understand batch trends.
- Presented on key learning from the deviations and also on process robustness of a manufacturing process.
Education
Master of Science - Microbiology
Andhra University
Visakhapatnam, India 2001.04 -
Skills
Upstream Manufacturing operations
Process Compliance
Documentation
Workflow management
Quality Management System
Process Validation
Languages
English
Bilingual or Proficient (C2)
Certification
Duolingo English Test
Timeline
Duolingo English Test
2024-03
Production Specialist
Dr Reddys Laboratories
2022.08 - Current
Technical Trainee
Dr Reddys Laboratories
2021.08 - 2022.07
Master of Science - Microbiology
Andhra University
2001.04 -
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