Quality Assurance Data Entry

Chidesha Jain

************@*****.***

210-***-**** (Cell)

**** ******* **** ****, ***. 3402, San Antonio, Texas 78229

Results-driven Quality Assurance Specialist with five years of experience in pharmaceutical industry.

Specialties:

● Equipment Validation/Qualification ● Quality Management System ● CAPA

● Microbiological Testing ● Packing Material Analysis ● Trend Analysis

Education:

Masters in Science, Biotechnology, Bangalore University, India (GPA 3.25) September 2007

Bachelors in Science, Biotechnology, Indore University, India (GPA 3.25) June 2005

Work Status:

No sponsorship is required. Eligible to work in the US.

Professional Experience:

USV Limited, Daman, India June 2011 – December 2011

Designation: Quality Assurance Specialist

Protocol Preparation and Analysis:

● Prepared and executed validation protocols per regulations and saved 20% of budgeted cost planned for 3 months

● Developed a functional specification checklist during the first 60-80 hours of the project to manage Inspection, Operation, and Performance Qualifications (IQ, OQ, and PQ)

Plethico Pharmaceuticals Limited, Indore, India September 2008 – June 2011

Designation: Quality Assurance Officer

Equipment and HVAC Validation:

● Established up to $1M worth of technical and maintenance tests’ reports based on environmental parameters

● Proposed preventive maintenance processes to keep the annual capital budget low by 15-20%

● Reviewed 10 CAPA reports and applied statistical and historical knowledge to produce the Validation Master Plan

Manufacturing and Packaging Operation:

● Collaborated with three clients in six months and discussed and developed packaging options considering physical protection, barrier protection, and convenience to use the medicine in the forms of injections, tablets, and capsules

● Lead a team of four members and successfully managed the transitioning of medicines to warehouse for bulk handling and transport shipping

Quality Management System:

● Reviewed and signed reports to transfer products from development stage to manufacturing within 48 hours of initiation

● Designed 12 user-friendly reports and listed handling, packaging, and labeling details

● Prepared water trend chart per microbiological limits and recommended corrective actions

● Presented project details to a team of ten people during an audit conducted by Medicines and Healthcare products Regulatory Agency of United Kingdom (UK MHRA)

Akums Drugs and Pharmaceuticals Limited, Haridwar, India August 2007 – August 2008

Designation: Microbiologist Trainee

Data Analysis and Evaluation:

● Assisted in evaluating water sampling and testing and environmental monitoring reports

Computer Skills:

MS Office Suite, EMBOSSWIN

Awards and Achievements:

Presented a technical paper on the importance of the Internet and telecommunication October 2002

Collaborated with a team and worked on a project based on Molecular biology and rDNA technology August 2006

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