KIRAN NAIK
Quality Control Microbiologists
Surathkal, Mangalore
Summary
Objectives:- Seeking a position that offers the optimal opportunity to utilize my skills and abilities to make a positive contribution towards the organization. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
16
16
years of professional experience
1
1
Language
Work History
Junior Manager
Syngene International Limited
Mangalore
11.2019 - Current
- Method validation of Microbial limit tests (MLT) and all other applicable test .
- Review of specifications,standard operating procedure,Instrument operating procedure,observation data sheet,certificate of analysis.
- Training of personnel in Quality control microbiology.
- Ensure any time audit readiness in QC microbiology
- Review of LIMS/ELN samples as per requirement
- Periodic revalidation of Laminar air flow (LAF), Biosafety cabinet (BSc) and AHU validation
- Usage and maintenance of HPHV steam sterilize/Decontamination Autoclave
- Supported management protocols, decisions and plans within company structure, atmosphere and culture.
- Scheduled cross-team meetings, facilitated planning, note-taking and status updates for project execution.
- Supervised various tasks in quest of completing daily activity on time.
- Review sample information into laboratory information Management System (LIMS) 8
- To actively maintain and promote GMP, ensuring that the highest standards of housekeeping are maintained.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Engaged with key stakeholders and partners on needs and initiated efforts to define and document requirements.
- To follow the written procedure and documentation of any deviation, CAPA, OOS, change control and microbial investigation.
ASD Executive(Team Leader)
Sequent Research Limted
Mangalore
04.2017 - 11.2019
- 1.Method validation of Microbial limit tests (MLT) and all other applicable test 2
- Bacterial Endotoxin Test (BET) validation of API Product
- Periodic revalidation of Laminar air flow (LAF), Biosafety cabinet (BSc) and AHU validation
- Carry out preservative efficacy test (PET)
- Disinfectant validation Test (DET)
- Maintenance of media/dehydrated media and carry out growth promotion test
- Maintenance of culture suspension for GPT.Storage and Maintenance of stock for received media, relevant stock registers and log books, online documentation
- Bacterial Endotoxin Test of Product and Purified Water, Biological indicator Enumeration Test
- Carry out Environmental monitoring
- Usage and maintenance of HPHV steam sterilize/Decontamination Autoclave
- Review sample information into laboratory information Management System (LIMS)
- Daily equipment checks and calibration.
- Reviewing all microbiology online documents
- To follow the written procedure and documentation of any deviation, CAPA, OOS, change control and microbial investigation.
- Isolation, subculturing and maintenance of oraganism.Water analysis.
QC Executive
Kemwell Biopharma Pvt. Ltd
Tumkur, Begur, Nelamangala Taluk, Bangalore
10.2014 - 03.2017
- Handling Microbiology Contract Stability Study for AD-II(J&J) samples,Microbial limit tests (MLT), Method Transfer
- Receipt, storage handling and maintenance of microbial pure cultures and Environmental microorganism
- Preparation and maintenance of Cryovials.Culture and Media Hold Time Study
- Disinfectant efficacy test for EMP isolates
- Carry out preservative efficacy test (PET)
- Biological indicator Enumeration Tests.
- Usage and maintenance of HPHV steam sterilizer/Decontamination Autoclave
- Preparation and maintenance of media/dehydrated media and carry out growth promotion test
- Preparation of culture suspension for GPT.Storage and Maintenance of stock for received media, relevant stock registers and log books, online documentation
- Water analysis and Operation and Calibration of Water activity meter
- To follow the written procedure and documentation of any deviation,CAPA,OOS, change control and microbial investigation.
Q.C officer
Nebumed Pharma, CIPLA Ltd
Verna
12.2010 - 09.2014
- Carry out Environmental monitoring in various area like FFS I,II,III,Nasal spray,Liquid Oral,Stores dept
- By Settle plate,Active air sampling,surface monitoring and Personal monitoring
- Environmental monitoring during media fill activity
- Preparation of media and carry out Growth Promotion Test (GPT)of dehydrated and ready to use media 3.Carry out Water Sampling and Analysis of Water For Injection,Purified, Potable,Broiler and Pure Steam condensate.Periodic Water Validation.Drain time validation
- Bacterial Endotoxin Tests.(BET),Endotoxin Spiking Recovery for Dry Heat Sterilizer Validation.Bioburden test for process sample,Microbial Limit Tests(MLT).Online documentation
- Handling in instrument like Fedigiri Autoclave,Discard autoclave,Dry Heat Sterilizer
- To keep check on Calibration Status
- To raise Indent and GRN for the material required for microbiology lab
- To perform log recording of Daily monitoring,checking media stock records.
Microbiologist
Venkys India Pvt Ltd, Diagnostic
Bangalore
04.2007 - 12.2010
- Carry out ELISA .Preparation of Various Selective,Non selective, Enrichment media.Culturing,Isolation & Identification of various pathogens like, E.Coli,Salmonella ,Staphylococcus aureus, Proteus,Klebsiella,Clostridium etc.Primary isolation & Preliminary Identification of Enteric Pathogen like Salmonella,Shigella
- Bacterial Meat & Feeds samples analysis tests like Total Count, E.Coli Count, Fungal count,Clostridia Count, Salmonella Count, Heat resistant bacterial count 3.Culture methods for Enumeration & Identification of Coli form & E.Coli in Foods, Determination of presumptive E.coli,Yeast &Moulds.
- Various Biochemical Test like TSI,Urease,SIM,Catalase,Oxidase,Indole,Carbohydrate Fermentation, Staining etc & Water test (MPN count,Ph,Hardness,Peroxide)
- Additional Qualification:
- Diploma in General Biotechnology (BEST BIOTEK RESEARCH LABS, BANGALORE)
- Computer Knowledge: - MS Office - MS word, MS excel
Education
Bsc - CBZ
Karnataka University Dharwad
Msc - Biotechnolgy
Karnataka University Dharwad
Skills
Operations management
undefinedAdditional Information
- Field of Interest :, Quality Control , Quality Assurance
- Permanent Address : Kiran Naik S/O N.P.Naik Health Dept.Talebagh, Keni Road,ANKOLA Karwar Dist,Karnataka-581314 Phone: 08388-230752
Timeline
Junior Manager
Syngene International Limited
11.2019 - Current
ASD Executive(Team Leader)
Sequent Research Limted
04.2017 - 11.2019
QC Executive
Kemwell Biopharma Pvt. Ltd
10.2014 - 03.2017
Q.C officer
Nebumed Pharma, CIPLA Ltd
12.2010 - 09.2014
Microbiologist
Venkys India Pvt Ltd, Diagnostic
04.2007 - 12.2010
Bsc - CBZ
Karnataka University Dharwad
Msc - Biotechnolgy
Karnataka University Dharwad
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