Siva Prasad A.
Hyderabad,TELANGANA
Summary
With over 20 years of experience in microbiology and quality assurance within the pharmaceutical industry, I bring extensive expertise in sterile injectable manufacturing. My focus is on ensuring compliance with global regulatory standards, including USFDA, MHRA, and WHO. I am committed to driving microbiological quality control, regulatory compliance, environmental monitoring strategies and leading high-performing teams to achieve operational excellence while maintaining superior product quality.
Overview
21
21
years of professional experience
5
5
years of post-secondary education
Work History
Senior Manager – QA
Eugia Pharma Specialties Ltd
Hyderabad
11.2015 - Current
- Company Overview: Formerly Aurobindo Pharma Ltd
- Oversee Microbiology Lab compliance and ensure adherence to cGMP, pharmacopeial, and regulatory requirements
- Lead external and regulatory audits (e.g., USFDA, Health Canada) and prepare audit responses
- Review and implement Microbiological Method Validations, SOPs, and GTPs
- Conduct Quality Risk Management (QRM) exercises for microbiology activities
- Ensure lab GMP compliance and stay updated with pharmacopeial guidelines
- Manage QMS activities such as deviations, CAPA, change controls, and exceptions
- Handling Microbiological failure investigations
- Formerly Aurobindo Pharma Ltd
Deputy Manager
JODAS Expoim Pvt Ltd
04.2014 - 10.2015
- Established a new Microbiology lab for sterile formulations
- Supported the setup of a new injectable facility and contributed in injectable filling line qualification
- Implemented Microbiological standard operating procedures for routine operations
- Performed external laboratory audits and ensured compliance with regulatory standards
Assistant Manager
Hospira Healthcare India Pvt Ltd
03.2010 - 02.2014
- Led the Microbiology team, overseeing microbiological testing of finished products (FP), raw materials (RM), in-process samples (IP), and packaging materials (PM)
- Managed method validation, environmental monitoring programs, and contamination control strategies while ensuring regulatory compliance, data integrity, and effective team leadership
- Contributed to area qualification by implementing a comprehensive viable environmental monitoring program, optimizing contamination control strategies in compliance with regulatory requirements
- Developed and analyzed trend charts for environmental monitoring and water systems, ensuring data-driven assessment of microbial and physicochemical quality in compliance with regulatory standards
- Actively engaged in internal audits, conducting gap assessments and ensuring adherence to cGMP, regulatory guidelines
Executive
Orchid Healthcare
02.2008 - 03.2010
- Performed sterility testing, BET testing, and product validations
- Ensured compliance with cGMP and GLP standards
Officer
Emcure Pharmaceuticals
02.2006 - 02.2008
- Conducted environmental monitoring, sterility testing, and BET testing
- Performed IPQA activities for batch dispensing, manufacturing, and filling
- Prepared SOPs, validation protocols, and maintained microbial cultures
Quality Control Microbiologist
Macleods Pharmaceuticals
09.2004 - 02.2006
- Conducted water sampling, sterility testing, and environmental monitoring in sterile and non-sterile areas
- Performed microbiological assays and maintained microbial cultures
- Played a pivotal role in establishing new Microbiology labs and sterile injectable facilities
Education
M.Sc. - Applied Microbiology
Bharathidasan University
01.2000 - 01.2002
B.Sc. - Microbiology, Biochemistry, Aquaculture
Nagarjuna University
01.1997 - 01.2000
Skills
development and validation of microbiological test methods
traditional microbiological methods
rapid microbiological methods (RMMs)
Sterility Assurance
Aseptic processing
contamination control strategies
microbiological failure investigations
root cause analysis
corrective and preventive actions (CAPAs)
environmental and utility monitoring programs
identification and assessment of microbiological risks
undefinedAccomplishments
- Successfully participated in multiple regulatory audits, demonstrating compliance with global quality and microbiology standards. Key audit experiences include:
- USFDA Audits: Eugia Pharma Specialties Ltd, Hospira Healthcare, Emcure Pharmaceuticals
- MHRA Audits: Hospira Healthcare, Orchid Healthcare
- WHO Audits: Macleods Pharmaceuticals
- Other Regulatory Audits: ANVISA (Brazil), Health Canada, Colombia, Japan, Ukraine, and IDA
- Effectively contributed to audit preparedness, regulatory responses, and implementation of corrective and preventive actions (CAPAs) to uphold cGMP compliance.
Personal Information
- Date of Birth: 01/08/80
- Marital Status: Married
Timeline
Senior Manager – QA
Eugia Pharma Specialties Ltd
11.2015 - Current
Deputy Manager
JODAS Expoim Pvt Ltd
04.2014 - 10.2015
Assistant Manager
Hospira Healthcare India Pvt Ltd
03.2010 - 02.2014
Executive
Orchid Healthcare
02.2008 - 03.2010
Officer
Emcure Pharmaceuticals
02.2006 - 02.2008
Quality Control Microbiologist
Macleods Pharmaceuticals
09.2004 - 02.2006
M.Sc. - Applied Microbiology
Bharathidasan University
01.2000 - 01.2002
B.Sc. - Microbiology, Biochemistry, Aquaculture
Nagarjuna University
01.1997 - 01.2000
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