K. Satyanarayana
Visakhapatnam
Summary
Dedicated Quality Control (Microbiology) professional with 15+ years of experience in the pharmaceuticals QC Operations, Microbiological analysis, lab compliance, QMS systems and team leadership.
Overview
16
16
years of professional experience
Work History
Section Head -Quality Control (Microbiology)
Dr.Reddy's Laboratories
Srikakulam
05.2022 - Current
- Supervised daily operations of the section including planning, organizing, staffing, directing and controlling activities.
- Ensured compliance with established policies, procedures, regulations and internal controls within the section.
- Managed automated QMS activities for deviations, OOS, and change controls to ensure compliance and operational integrity.
- Prepared monthly and yearly trends for water and environmental monitoring to support compliance and decision-making.
- Preparing and reviewing SOP and Protocols through automated system (Dochub, i create).
- Supporting audits, Compliance and Method validations activities.
- Established effective communication channels between all departments involved in operations of the section.
- Identified staff training needs and developed targeted training programs to enhance team competency and performance.
- Ordered laboratory consumables and media using SAP to ensure adequate supply.
Junior Manager in Quality Control (Microbiology)
Eisai Pharmaceuticals India Pvt.Ltd.
Visakhapatnam
05.2016 - 04.2022
- Handling of Analytical and Lab support team of Microbiology:
- Planned and reviewed regular analytical and lab support activities, including media, water, culture, and environmental monitoring.
- Accepted and allotted activities to analysts through LIMS.
- Reviewed completed activities through LIMS, including water, product, environmental monitoring, in-process samples, and swab samples.
- Handled troubleshooting in the microbiology department.
- Handled the automated QMS, including reviewing and tracking change controls.
- Prepared and reviewed SOPs in the microbiology department using automated systems like Trackwise and DMS.
- Prepared and reviewed protocols in the microbiology department.
- Prepared investigation reports and conducted reviews to ensure timely closure.
- Team lead for Lab compliance and online lab compliance.
- Support for the QMS activities in the department.
- Verification and implementation checks for all scheduled activities in the laboratory.
- Support for all validation activities.
- Participated in audit and compliance closure tasks.
- Indented laboratory consumables through ERP on a monthly basis.
- Identification of new isolates by using VITEK 2.
- Prepared monthly and yearly trends for water and environmental monitoring.
- Preparation of culture Media and perform Growth promotion tests.
- Environmental monitoring (Settle plate, Active air sampling and compressed air).
- Perform Microbial and chemical analysis of Purified water, Potable water and Raw water.
- Perform Microbial limit tests for Raw material, Finished products, stability samples and in process samples.
- Swab sampling and Analysis of cleaning validation, verification and hold time studies of production equipment’s.
QC chemist (Microbiology)
Gland Pharma Ltd, UNIT-I
Duvvada
09.2011 - 05.2016
- Performed bacterial endotoxin testing on water, finished products, and stability samples to ensure product safety and regulatory compliance.
- Microbial limit test for RM, Finished and stability products.
- Microbial and chemical analysis of water.
- Validation of Disinfectants.
- Method validations for BET and Microbial Limit test.
- Media preparation and Growth promotion test.
- Conducted environmental monitoring ensuring compliance with safety standards to maintain quality assurance.
- Online documentation and maintenance.
- Participated in regulatory audits by USFDA, WHO, and customers, contributing to successful compliance verification and quality assurance.
QC Officer (Microbiology)
Oncotech Services
Kurmannapalem
07.2010 - 08.2011
- Performed microbial analysis of water to ensure safety and quality for consumption.
- Executed microbial limit tests on finished pharmaceutical products to verify compliance with safety regulations.
- Conducted environmental monitoring to evaluate ecological health and ensure compliance with regulatory standards.
- Media preparation and Growth promotion test.
Education
Master of Science (M.Sc) - Biotechnology
Andhra University
Andhra Pradesh05-2006
Bachelor of Science (B.Sc) - Microbiology
Andhra University
Andhra Pradesh01-2003
Skills
- Quality Assurance Strategy
- Laboratory Information Systems
- Regulatory compliance
- Laboratory management
- Cross-Functional Collaboration
- Team leadership
- Analytical team player
- Continuous learning
Hobbies and Interests
- Reading books
- Browsing
- Playing cricket
Projects
Micro Biological Examination of Water and Finished Product according to British Pharmacopoeia standards., DR.REDDY’S LABORATORIES, Pydibheemavaram, Srikakulam
Disclaimer
I hereby affirm that the information in this document is accurate and true to the best of my knowledge.
Languages
- English
- Hindi
- Telugu
Personal Information
- Father's Name: K.Simmayya
- Date of Birth: 07/01/83
Timeline
Section Head -Quality Control (Microbiology)
Dr.Reddy's Laboratories
05.2022 - Current
Junior Manager in Quality Control (Microbiology)
Eisai Pharmaceuticals India Pvt.Ltd.
05.2016 - 04.2022
QC chemist (Microbiology)
Gland Pharma Ltd, UNIT-I
09.2011 - 05.2016
QC Officer (Microbiology)
Oncotech Services
07.2010 - 08.2011
Master of Science (M.Sc) - Biotechnology
Andhra University
Bachelor of Science (B.Sc) - Microbiology
Andhra University