Veera Reddy Kotha
Summary
Result driven and dedicate with 18 years of experience in planning and leading activities involving in medium and large sized pharmaceutical and Biotechnology manufacturing environments. Established effective Quality Assurance and Manufacturing processes. Excellent communicator, worked with success building cohesive teams focused on Quality Goals, objectives, compliance, and throughput.
Overview
18
18
years of professional experience
Work History
Group Manger
Pfizer India Health Care Limited, Visakhapatnam.
2018.11 - Current
- Responsible to Lead the Investigations and find the root cause and implement right CAPAs.
- Develop Site Quality metrics in align with Pfizer global metrics.
- Lead Quality Systems and act as site Change Process Owner.
- Implementation of Quality Improvement Projects.
Lead –Quality Operations (IPQA)
Mylan Laboratories
Bangalore
2015.12 - 2018.11
- Manage the Manufacturing Quality Operations (IPQA) from Dispensing, Formulation, Aseptic Filling, Visual Inspection and Packaging Activities.
Assistant Manager – Vaccines Drug Substance QA
SHANTHA BIOTECH (A Sanofi Company)
2010.12 - 2015.12
- Responsible for In Process Quality Assurance activities for Sterile Drug Substances
- Planning and Execution of Media Fills and APQR preparations
Assistant Manager-Vaccines Drug Substances Manufacturing
BIOLOGICAL. E. Ltd.
2007.01 - 2010.11
- Responsible for production of Whole Cell Pertussis, and Pneumococcal conjugate sterile antigen (in collaboration with Merck-USA).
Executive – Manufacturing
Aurobindo Pharma Ltd.
Hyderabad
2005.08 - 2006.12
- Manufacturing of Sterile Cephalosporins.
Education
Master of Science in Microbiology -
Babasaheb Ambedkar University, Aurangabad. India.
Bachelor’s Degree in Microbiology -
Osmania University, Hyderabad, India.
Skills
- Sterile Manufacturing Quality Assurance
- Operations Management
- Root Cause Analysis
- Corrective Action Planning
- Continuous Improvement
- Compliance Requirements
- Audit Process Coordination
- Document Review
- Staff Training
- Audit Assistance
- Quality SOPs Development
- Corrective Actions
- Inspections and Audits
Areas Of Experience
- Investigations, Quality Network Services and Quality Systems-Group Manger
- Pfizer electronic Log-book Site deployment lead
- Quality Operations (IPQA)- Sterile pharmaceuticals Drug Product Lead
- Quality Operations (IPQA)- Sterile pharmaceuticals Drug Substance Lead
- Drug Substance Manufacturing – Team Lead
Languages
Telugu,
First Language
English
Advanced
C1
Hindi
Upper Intermediate
B2
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Group Manger
Pfizer India Health Care Limited, Visakhapatnam.
2018.11 - Current
Lead –Quality Operations (IPQA)
Mylan Laboratories
2015.12 - 2018.11
Assistant Manager – Vaccines Drug Substance QA
SHANTHA BIOTECH (A Sanofi Company)
2010.12 - 2015.12
Assistant Manager-Vaccines Drug Substances Manufacturing
BIOLOGICAL. E. Ltd.
2007.01 - 2010.11
Executive – Manufacturing
Aurobindo Pharma Ltd.
2005.08 - 2006.12
Master of Science in Microbiology -
Babasaheb Ambedkar University, Aurangabad. India.
Bachelor’s Degree in Microbiology -
Osmania University, Hyderabad, India.
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