SUMMARY:

Certified FDA approved Microbiologist with the background of Masters of Science in Microbiology.

** ***** ** ********* ********** in Quality Control & Microbiology departments in Pharmaceutical Industries.

Well versed with Good Laboratory Practices, GMP, SOP, CAPA, OOS, OOT and other established standards and ensured the work performed in full compliance with them.

Expertise in performing wet, instrumental and microbiology methods of analysis.

Superior multi-tasking, trouble shooting, flexible and organizational skills in order to meet the needs of departments and organization.

Supervising of entire Quality Control activity in absence of Quality Control Assistance Manager.

Successfully represented microbiology department to ISO 14001: 2004, WHO – GMP, KFDA, US – FDA, MHRA, Indian FDA and Indian CDSCO auditors.

Proficient in LIMS software, SAP software, MS Word, Excel, PowerPoint, Outlook, Internet Applications and Windows Operating system.

Delivers an excellent customer experience, helping customers to choose the right product and/or service according to their requirements.

Provides technical help to colleagues if required.

Adopt new techniques to minimize the material wastage and minimize the time of analysis activity.

Demonstrative ability in Microbiological analysis.

EDUCATION:

Master of Science in Microbiology, Bangalore University, Bangalore, Karnataka, India

Post Graduate Diploma in Medical laboratory Technology, Veer Narmad South Gujarat University, Gujarat, India

Bachelor of Science in Microbiology, Veer Narmad South Gujarat University, Gujarat, India

EXPERIENCE:

Lupin Limited, Ankleshwar, Gujarat, India Duration: 31/08/2018 to 03/01/2020

Designation: Senior Executive

Responsibilities:

Supervise compliance to all cGMP, GLP or any other Regulatory Requirements including Environment Health and Safety requirements.

Complete Self-Training and monitor Training of team members on relevant SOPs, ISRS and Kavach.

Conduct all Tasks/Activities as per the applicable SOPs.

Report any Difficulty or Deviation in following the procedures/instructions to immediate Supervisor/Managers.

Report any Quality Concerns or Suggestions for improvements to Supervisors/Managers.

Daily allocation of work related to Microbiology section to concerned Analysts.

Releasing/Rejecting all Raw Materials, Packaging Materials, In-process samples and Microbiological Samples.

Initiation of CAPA, Change Controls and Deviations related to Microbiology.

Discussion of Out Of Specification results with the QC Head & initiation of investigation of such results.

Handling and Investigation of Laboratory Incidents related to Microbiology Section.

Upkeep of the Laboratory working areas and observe the Good Laboratory Practices.

Review of analytical documents related to Microbiology Section.

Handling of Quality Improvement project.

Preparing and updating Standard Operating Procedures / Specifications / Protocols / Reports.

Reporting of sectional activities to Department Head as per Schedule.

Alkem laboratories Limited, Mandva (Ankleshwar), Gujarat, India Duration: 22/12/2014 to 27/08/2018

Designation: Senior Officer

Responsibilities:

Environment Monitoring & Air sampling of formulation area, API area, Microbiology Laboratory area.

Trend data preparation for water analysis and environment monitoring.

Performs testing of Raw Water, Process Water, Potable Water, & Purified Water.

Purified Water analysis by Membrane Filtration Method.

Analysis of Finished Products.

Calibration and Operation of Total organic Carbon Analyzer (Shimadzu).

Performs Microbial Limit Test, Test for Specified Microorganisms.

Media preparation and Growth Promotion Testing of culture medias.

Day to day checking of records like clean room monitoring, sterilization records, etc. related to microbiology and microbiological testing.

Maintenance, Preservation & Preparation of Microbial Culture and Culture Suspensions, Cell Enumeration, Storage & Destruction.

Operation of HPHV (High Pressure High Vacuum) Autoclave, Vertical Autoclave, Laminar Air Flow, Water Bath & Incubators.

Water system and Area Qualification related activities.

Preparation of SOPs and Qualification protocols and reports.

Look out the internal and external calibration & validation related activity & maintain the microbiology area as per GMP.

Complete involvement in customer and regulatory audits.

Glenmark Generics Limited, Ankleshwar, Gujarat, India Duration: 20/01/2010 to 17/12/2014

Designation: Officer

Responsibilities:

Environment Monitoring & Air sampling of formulation area, API area, Microbiology Laboratory area & Perform Compressed Air Sampling.

Trend data preparation for water analysis and environment monitoring.

Performs testing of Potable Water, Purified Water & WFI Water.

Perform Bacterial Endotoxin test.

Validation of Water System.

Analysis of Finished Products, Raw Materials and Stability Samples.

Calibration and Operation of Total organic Carbon Analyzer (Shimadzu).

Performs Microbial Limit Test, Test for Specified Microorganisms.

Media preparation and Growth Promotion Testing of culture medias.

Day to day checking of records like clean room monitoring, sterilization records, etc. related to microbiology and microbiological testing.

Maintenance, Preservation & Preparation of Microbial Culture and Culture Suspensions, Cell Enumeration, Storage & Destruction.

Operation and Calibration of Vertical Autoclave, Laminar Air Flow, Water Bath & Incubators.

Look out the internal and external calibration related activity & maintain the microbiology area as per GMP.

Operation and timely calibration of all instruments (TOC Analyzer, Refrigerators, Dryer, DHS, Analytical Balance, pH / Conductivity Meter, Heating Block etc.).

Complete involvement in customer and regulatory audits.

DECLERATION:

I declare that above mentioned details are true with the best of my knowledge.

Bhavik G. Gohil

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