S B R N V Prasad
Micobiology laboratory incharge
Hyderabad
Summary
15 years of experience in quality control microbiology Department.
Maintain quality of the process/highly advance instruments as per regulatory USFDA, NVISA, KFDA, and Health Canada, WHO Geneva, TGA and CDSCO norms.
Leading team of 11 members to achieve TAT.
Overview
15
15
years of professional experience
5
5
years of post-secondary education
Work History
Lab in charge – Deputy Manager
Aurobindo Pharma Ltd
08.2020 - Current
- Planning, and assigning work tasks and activities with smooth execution to the team members
- Handling of Market / customer complaints, investigation of Out of specifications/ trends, incidents, deviations and Risk assessments
- Induction, personal qualification, requalification on job training of microbiologists
- Change management system – Change controls, Change effectiveness
- CAPA – Corrective action and Preventive action of investigations
- CAPA effectiveness analysis
- Tool Used- Histogram, Pareto charts (80/20), Fish bone (5 why)
- Day to day work planning - Team handling and cGMP
- Preparation of SOP, STP, GTP in line with current guidelines
- Cost reduction analysis without impact the quality
- Impact assessment analysis and implementation of best process without impact the regulatory Norms
- Procurement of lab Chemical and materials – EPR (oracle) /SAP
- Responsible for Regulatory Audit, Market complaint
- LAB management – planning, execution and release of report
- Developing and managing the operational budget and capital expenditure proposal for the laboratory equipment and system to ensure achievement of operational targets
- Preparation, revision and implementation of SOPs related to the Microbiology laboratory in order to maintain compliance with GLP and current regulatory expectations
- Instrument and process development: Procurement of Instruments – URS, indent, DQ, FAT, SAT, UAT, IQ, OQ, PQ, CSV of GXP system (as per GAMP-5)
- Auditor: Qualified internal auditor for periodic audits at site
- Auditee for all regulator audits like USFDA, NVISA, KFDA, Health Canada, WHO Geneva and CDSCO
Executive
Aurobindo Pharma Ltd
08.2015 - 07.2020
- Day to day work planning
- Maintaining cGMP in microbiology lab
- Responsible for lab ware Procurements
- Responsible for Audit preparation
- Bacterial Endotoxin Test for Drug Product and Water using the Gel Clot Assay Raw Material Release Testing Microbial Limits/Bio burden/Microbial
- Validations executed – BET, MLT, Autoclave validation, disinfectant
- Preparation of SOP, STP, GTP in line with current guidelines
- Handling change control management system with cross functional team in TrackWise Quality Management Software
- Handling incidents, deviations, CAPA
Reviewer
Dr. Reddy’s
09.2009 - 08.2015
- Review of analytical data
- Analysis of water, finished product, environmental monitoring samples
- Day to day work planning
- Trend preparation
- Media preparation, handling and maintenance
- Calibration and preventive maintenance of analytical instruments
- Change controls initiation and closing
- MLT and BET validation of API
- Bacterial Endotoxin Test for Drug Product and Water using the Gel Clot Assay Raw Material Release Testing Microbial Limits/Bio burden/Microbial
Education
B.Sc. - Microbiology, Biochemistry
S.V.K.P & Dr Raju Arts &Science College
01.2003 - 01.2006
M.Sc. - Microbiology
T.S.R. & T.B.K College
Srinagar gajuwaka, Visakhapatnam 01.2006 - 01.2008
Skills
TOC analyzer (GXP system)
Bacti-flow
Autoclave (horizontal and vertical)
Hot Air Oven (GXP system)
Laminar Air Flow
Microscope
pH meter
Incubator (GXP system)
Conductivity Meter
Colony counter
Bio safety cabinet
Air Sampler (GXP system)
BOD incubator
LIMS
ERP
Oracle Agile system
ICDAS 21
Lab solution
Microsoft Office
Skills
TOC analyzer (GXP system), Bacti-flow, Autoclave (horizontal and vertical), Hot Air Oven (GXP system), Laminar Air Flow, Microscope, pH meter, Incubator (GXP system), Conductivity Meter, Colony counter, Bio safety cabinet, Air Sampler (GXP system), BOD incubator, LIMS, ERP, Oracle Agile system, ICDAS 2.1, Lab solution, Microsoft Office
Timeline
Lab in charge – Deputy Manager
Aurobindo Pharma Ltd
08.2020 - Current
Executive
Aurobindo Pharma Ltd
08.2015 - 07.2020
Reviewer
Dr. Reddy’s
09.2009 - 08.2015
M.Sc. - Microbiology
T.S.R. & T.B.K College
01.2006 - 01.2008
B.Sc. - Microbiology, Biochemistry
S.V.K.P & Dr Raju Arts &Science College
01.2003 - 01.2006