Experienced pharmaceutical professional with 15 years in API manufacturing operations and production management within cGMP environments. Currently serving as Production Manager, specializing in production planning, process optimization, and regulatory compliance. Proven capability in leading commercial-scale operations while ensuring safety, quality, and documentation adherence.
Overview
3
3
Languages
1
1
Certification
16
16
years of professional experience
Work History
Production Manager
Optimus Drugs Pvt. Ltd. – Unit-I, Hyderabad
01.2013 - Current
Managing end-to-end API production activities in compliance with cGMP and SOP requirements.
Planning procurement requirements and coordinating raw material availability for production.
Preparing and monitoring daily/weekly/monthly production schedules.
Preparation and review of BPRs, validation protocols, and validation reports.
Handling product quality risk assessments and change control activities.
Preparation and revision of SOPs and related GMP documents.
Assessing equipment suitability for new and existing products.
Monitoring batch manufacturing activities and ensuring timely completion of production schedules.
Handling manpower planning, shift management, and operational coordination.
Reviewing BMR/BPR documentation and ensuring compliance with quality systems.
Coordinating with QA, QC, Warehouse, Engineering, and EHS departments for smooth operations.
Supporting regulatory audits and implementing CAPA activities.
Monitoring process performance, yield improvement, and equipment utilization.
Ensuring adherence to safety procedures and plant compliance standards.
Key Achievements
Successfully managed commercial-scale API manufacturing operations.
Improved production efficiency through effective manpower and process management.
Achieved yield and process improvements through optimization initiatives.
Supported successful regulatory audits including USFDA, WHO, and customer audits.
Maintained compliance with cGMP and safety standards.
Managed cross-functional production teams and shop floor operations effectively.
Production Department
Mylan Laboratories (Now Viatris), Hyderabad
01.2010 - 01.2012
Executed API manufacturing activities following approved batch procedures to ensure quality standards.
Executed API manufacturing activities as per approved batch procedures.
Coordinated with QA and maintenance teams during batch execution.
Coordinated with QA and maintenance teams during batch execution to maintain compliance and operational efficiency.
Participated in process troubleshooting and operational activities to enhance overall production effectiveness.
Education
PGDM - Operations Management
MIT School of Distance Education
Pune
12-2026
Bachelor of Science (B.Sc.) - undefined
Osmania University
Hyderabad
01-2010
Skills
Production Planning & Scheduling
cGMP Compliance
Validation Documentation
BPR/BMR Preparation & Review
Validation Protocol & Report Preparation
Product Quality Risk Assessment
Change Control Management
SOP Preparation & Revision
Process Flow Chart Preparation
Equipment Qualification & Suitability Assessment
Raw Material Planning & Procurement Coordination
API Production Operations
Audit readiness
Workforce Coordination
Certification
Yellow Belt Certification in Lean Six Sigma
Timeline
Production Manager
Optimus Drugs Pvt. Ltd. – Unit-I, Hyderabad
01.2013 - Current
Production Department
Mylan Laboratories (Now Viatris), Hyderabad
01.2010 - 01.2012
Bachelor of Science (B.Sc.) - undefined
Osmania University
PGDM - Operations Management
MIT School of Distance Education
EQUIPMENT / PROCESS EXPOSURE
Reactors
Centrifuges
ANFD
Dryers
Distillation Systems
Filtration Systems
Solvent Recovery Systems
Material Handling Equipment
ADDITIONAL INFORMATION
Exposure to regulatory audits including USFDA, WHO, and customer audits.
Experience in managing production manpower and cross-functional teams.
Proven involvement in yield improvement and process optimization initiatives.
DECLARATION
I hereby declare that the above information is true and correct to the best of my knowledge and belief. Vuppala Venkatesh