Quality Control/Quality Assurance
Resume:
NISHTHA N BHATT
North Brunswick, NJ 08902 **************@*****.***
Profile:
Looking for a full-time position in Pharmaceutical Industry, where I can demonstrate my technical and experimental skills and contribute to the development and better understanding of science for benefit.
Summary:
Highly organized and efficient in fast-paced multitasking environments, able to prioritize effectively to accomplish objectives with creativity and enthusiasm.
Professional Experience:
Sun Pharmaceuticals, Cranbury, NJ,USA 0ct-Dec 2016
Manufacturing Operator (Contract)
Setup, operate clean and troubleshoot equipment.
Follow batch record and SOPs instructions and on time completion of document activities on Batch record and log books.
Weighs/Dispense raw material per batch record instructions.
Material handling and all other job related duties.
Wal-Mart, North Brunswick, NJ, USA
Department Manager Feb 2014- Oct 2016
Own a Department with Inventory and audits.
Supervising Associate and distribution of tasks according to plan.
Verifying laws and outs of items and maintaining their records.
Documentation work related to everyday project and review of reports.
Additional duties assigned by supervisor.
Span Diagnostics Pvt. Ltd., Surat, Gujarat, India Jan 2013-Jan 2014
QA/QC Microbiologist
●Analysis of Finished Product, Intermediates & Raw Materials as per current specification & maintaining their records.
●Verify the cleanliness of rooms and equipment, and perform line clearance activity in the manufacturing and packaging area.
●Calibration of instruments & Analytical Method Validation. Stability Studies of product as per ICH Guidelines.
●Online BMR review and Random sampling of in process and finished product.
●Pure culture of various microorganisms and culture revival. Sensitivity of bacterial culture against different antibiotics.
●Sterility testing and viability testing such as Direct Transfer & Closed-System Membrane Filtration.
●Water testing all chemical test & COD & BOD.
●Sterility test for serology & routine and non- routine microbiological test for Raw materials, Intermediates and Finished products.
●Verify manufacturing activity and review of BMR at manufacturing process end stage.
●AQL visual Inspection of Finished Bulk product and collect samples for QA Testing.
●Calibration and maintenance of laboratory equipment as well as supplies inventory products.
●Collect and Compile data for annual Product review.
●Collect retain samples and perform annual visual inspection of retain samples.
●Maintain QA hold Log book and documentation work regarding ISO-QMS / WHO-GMP for serology and microbiology products as well understanding of FDA c GMP regulations.
●Additional duties as assigned by the supervisor.
Research Experience:
Indian Institute of Advanced Research, Gandhinagar, Gujarat, India
Research Trainee
6+ months
Identification and Isolation of bacteria using various microbial techniques.
Preparation of various media.
Maintain aseptic Environment using various sterile techniques.
Antibiotic Susceptibility test to Drug Resistance towards some classes of Antibiotics.
Maintain and sterile laboratory equipments.
DNA and RNA Isolation.
Genomic and Plasmid Isolation using various Isolation techniques.
Skills:
Operation and Calibration of all Major Microbiological and Biotechnological Instruments.
Very Good Knowledge of Microsoft Office as well mathematical skill and good knowledge of SAP 6.2 and SAS 9.4.
Knowledge of Manufacturing operation and label inspection.
Excellent Writing and communication skills.
Exceptional leadership skill.
Very good team work.
Research Skills:
Successfully Studied 35 isolates of Shigella spp. derived from actual Patients.
All 35 isolates of Shigella spp. were analyzed for antimicrobial susceptibility test and result show 91% strains resistant to Streptomycin and Trimethoprime while 85% strains resistant to Tetracycline.
Genomic and Plasmid Isolation and L2, L3 PCR analysis of 35 isolates of Shigella confirmed the presence of multiple plasmid and Class 1 Integrons.
Education
Veer Narmad South Gujarat University, Surat, Gujarat, India
2011-2013
Masters, Biotechnology
Veer Narmad South South Gujarat University, Surat, Gujarat, India
2008-2011
Bachelors, Biotechnology
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