Quality Control Microbiology

Kalpesh Thakkar, Contact: 214-***-****

SUMMARY:

My current role as a QC Microbiology Associate II, includes microbial analysis (bioburden, endotoxin, sterility testing, growth promotion, and microbial identification) of the samples, developing study protocols (such as sanitizer qualification), create/update SOPs, writing investigations, deviations, and trending reports for environmental monitoring of the cleanrooms and critical systems. Designed gowning qualification and media fill read qualification. I collaborate across multifunctional teams for aseptic techniques inside the cleanroom and laboratory. Actively involved in the system/site performance qualification (PQ), set alert level specifications, and representing the team during internal, the clients, and regulatory (ISO and FDA) audits as a subject matter expert (SME) of microbiology topics.

I have nine (9) years of education in pharmacy, microbiology, and biotechnology and more than 6 years of industrial experience in healthcare / pharmaceuticals / biopharmaceuticals sector. I am motivated, success driven, and a team player with a very strong background in QC/QA. Also, highly organized and have an exceptional ability to adapt quickly and efficiently to new challenges and meet project goals in a timely manner. My supervisory experience includes mentoring interns, technicians, assistants, and associates, provide technical knowledge to other teams of the company, and act as a backup in absence of the supervisor.

Technical Knowledge:

Instruments: Biotek plate reader for Endotoxin (Kinetic turbidometric-Lonza), PTS Endosafe for rapid endotoxin, Vitek 2 (microbial identification), Microscopy, Spectrophotometer, Particle Measuring System (PMS), Environmental monitoring instruments, and Sterility testing isolator.

Software: Microsoft office (Word, Excel, Power point, Outlook, and Projects), Laboratory Information Management System (LIMS), PMS, Track wise, Maximo (work orders/calibrations), EDMS for change requests, and SCADA Systems.

Compliance/Regulations: cGMP, cGLP, cGDP, EHS, ICH, ISO, CFR, USP and other compendia methods, FDA, and cleanroom/aseptic qualification/techniques.

PROFESSIONAL EXPERIENCES:

Cook Pharmica LLC. 11/2009-present

QC Microbiology Associate II

• Proficient in environmental monitoring of the critical systems (viable air, total particulates, water, and gas testing). SME for bioburden analysis and aseptic technique qualifications. Experience with bioburden method suitability, sterility testing of finished products, sterility method suitability (bacteriostasis and fungistasis) testing, growth promotion of media, microbial identification of mold (microscopy) and bacteria (vitek 2), conductivity testing, spore enumeration, endotoxin testing (kinetic turbidometric and rapid endosafe), biological indicator processing, and maintain in house organisms for growth promotion and enumeration.

• Lead investigations and deviations (trackwise) for out of level and out of specification results and other compliance issues then create/drive proper corrective and preventive actions (CAPA) to resolve it. Also, created templates and process flow for the investigations. Serve as a technical support for the PMS and investigate total particulate excursions inside the barrier isolators. Developed review of environmental monitoring trending data for critical systems, writing summary reports, and updated old trending reports.

• Mentor QC Microbiology associates to read/review microbiology results, documentation (enter in to LIMS and update the batch records). Lead projects concerning qualification of analytical methods, instruments, and external audit observations. SME for sanitizer qualification and other validation/qualification studies. Designed Media fill read and gowning qualifications. Experience with PQ of cleanrooms and systems, setting alert levels for cleanroom results.

• Trained new hires, technicians, and other departments for aseptic techniques. Represented QC microbiology department in the internal, clients, and regulatory (FDA and ISO) audits for justification of investigations, improvement/development study protocols, and environmental monitoring trending reports. Recognized for the technical knowledge and excellent work ethics. QC Microbiology point of contact as a subject matter expert for microbiology/validation qualification studies, investigations, deviations, batch record entries, PMS, and trending reports.

Hester Biosciences Ltd, Gujarat. 06/2005 - 07/2006

Production Executive (Microbiologist)

• Manufactured bacterial biomass using bioreactor batch fermentation and viral biomass by virus propagation in specific pathogen free embryos or tissue culture techniques. Experience in production of vaccines by concentration, emulsification, and Lyophilization. Analysis of products by Optical Density, Colony counts, and ELISA techniques.

• Environmental Monitoring of manufacturing environments. Analysis of in process and finished products for compliance with the CGMP and regulatory (ISO) requirements. Documentation of data for compliance and regulatory audits.

Helly Health Care Pvt Ltd, Ahmadabad. 06/2003 - 06/2005

Quality control Microbiology officer

• Developed environmental monitoring program for filling/manufacturing areas, microbial analysis (bioburden, endotoxin, coliform testing, and anaerobic testing) of in-process and finished products (packaged drinking water). Organism identification and investigation of out of specification results.

• Created SOPs for laboratory testing, environmental monitoring, and instrument operation. Maintained laboratory records and primary data in accordance with applicable regulatory and company policies. Keep abreast with new technology in microbiology, evaluate and investigate its applications for the laboratory.

Tuton Pharmaceuticals Ltd, Ahmadabad. 08/1999- 07/2000

Quality Assurance Officer

• Inspected and analyzed drugs (tablets, capsules, ointments and liquid drug preparations in process and finished) to ensure their compliance with FDA standards. Monitoring quality control lab and manufacturing area for compliance with cGLP and cGMP requirements.

• Collected in-process and finished product samples and performed routine assays like disintegration, hardness, and viscosity. Developed SOPs for manufacturing and QA departments. Maintained and presented test results during the regulatory inspections.

EDUCATIONAL DETAILS:

• M.S Biotechnology from The University of Texas at Dallas, August 2008

• M.S in Microbiology from Gujarat University, India 2005

• B.S in Microbiology from Gujarat University, India 2003

• Diploma in Pharmacy from Gujarat University, India 1999

PROFESSIONAL TRAININGS:

• Finease Pharmaceuticals in Quality Control Department as a “project intern”. 10/ 2003- 12/2003.

• Civil Hospital, Ahmadabad, as a “Hospital Pharmacist” 06/1999 -09/1999.

• Presented a poster on “Microbial testing of city water” in a regional symposium, 02/2005.

• Attended Conferences: 1-PMF Microbial Data Deviations: Investigations and Risk, 2- Particle Measuring Systems, Particle College, and 3-Performance of Disinfectant Qualification and how to avoid errors, 2010 USA.

References: Available upon request.

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