Objective:

Looking for challenging position in Quality department to utilize my skills and knowledge to ensure legal compliance, expectation and benefits of the firm.

• Advanced knowledge of different of regulatory guidelines like cGMP, GLP, GDP and safety guidelines.
• Better knowledge of all principle pharmaceutical technology and analytical processes and concepts.
• Working level experience of analytical techniques such as HPLC , TLC, IR , Dissolution and UV
• Sound theatrical background and detailed knowledge of test methods like Chromatography, Titrations and Dissolution
• Proficient with Microsoft Office products like Word, Excel, Project, Visio, PowerPoint, Windows XP/Vista/7
• Excellent communication skill, better team handling ability
• Planned and organized approach towards work, problem solving approach.

Quality Control Chemist March2011-Continue
Confidential, (Rahway, NJ)

• Performing calibration, maintenance and routine sample analysis of the laboratory equipment like pHmeter, Spectrofluorophotometer, UV spectrophotometer, FTIR, Polarimeter, Refrectometer, Dissolution unit, KF titration, HPLC, GC, Atomic Absorption
• Performing routine testing , releasing of raw materials , blend testing, inprocess material, finished products and stability testing.
• Maintenance of lab documents according to GLP guidelines, current USP and filled up log files regularly and kept it up to date
• Performing assay, dissolution, content uniformity, blend uniformity, impurity, disintegration, disintegration and other test
• Maintenance of water system by sampling, testing, releasing along with log book entry and documentation and record tracking
• Revising methods for rawmaterial , SOP as per USP and cGMP requirement and filling changecontrol for them.
• Tracking and maintenance of all laboratory documents, reports as per GDP
• Preparation of method validation protocols through R &D projects, method preparation, SOP preparation

Manufacturing Associate & Apprentice May2007- March2008
Formulation and Quality Control department
Confidential

• Active participation in QA committees.
• Analyze the data, identify problem and perform root cause analysis by different suitable methods
• Calibration of the lab equipment like pH meter and Weighing Scale and preparation of Reagent and Sample
• Maintenance of documents according to GLP guidelines and filled up log files regularly and kept it up to date
• Physical & chemical testing and approval of raw material, in-process and finished products
• Sample analysis by using HPLC, UV and IR Spectroscopy and documentation
• Analyze Deviation reports, Validation reports, tracking Document Status and performed Internal Audits
• Active participation in method validation, instrument qualification and stability study.
• Active participation in quality program to work with the other department in implementing the quality standers and benchmarks.

Manufacturing Associate & Apprentice May 2006-July2006
Formulation and Development department
Confidential

• Conducted Capsule Filling & Polishing, Performed Tablet Compression using Rotary Tablet Press as per SOP
• Processed blending and granulation operation using V- blender, Planetary mixture and Fluid Bed Granulator
• Gained experience of Film and Sugar Coating for the batch using large scale coating pan
• Ensuring and Maintaining the highest cGMP compliance & inspection readiness, Managing production activity
• Sound understanding of manufacturing records like Batch Manufacturing Records and Lot Summary Reports
• Remained current with and complied fully with cGMP, in-process specs & limits which helped to recognize deviation from procedures & production records
• Carried out testing like Disintegration, Dissolution, Friability and Hardness test according to Monographs
• Accompanied in collecting & analyzing data to identify root cause in failure investigation and in recommending CAPA

• “Application of innovative technologies in tablet formulation and manufacturing”-mainly focused on using advanced technology to develop new forms of dosage form, increasing output, reducing variability, reducing change overtime
• “Preparation and execution of IQ, OQ and PQ protocols for manufacturing equipments”
• “Develop and execute strategic plan to implement OSHA regulation in the pharmaceutical company to achieve OSHA STAR SITE recognition”
• “Design Aseptic plant and facility development according to cGMP and EMEA consideration”
• “ICH Q10-pharmaceutical Quality System”- FDA’s new initiative-successful application on pharmaceutical to get better FDA compliance and to improve Quality of product
• “Root cause analysis by different methods”

Stevens Institute of Technology
Master of Science in Pharmaceutical Manufacturing Practices

Coursework:

• Good Manufacturing Practices in Pharmaceutical Facility Design
• Validation and Regulatory Affairs
• Quality in Pharmaceutical Manufacturing
• Biotechnology & facility Design
• Design Management of Aseptic Pharmaceutical Manufacturing Process,
• Project Management
• Engineering Economics and Cost Analysis

• “Bio-process Systems Pharmaceutical Manufacturing”
• “Pharmaceutical Manufacturing Practices”

Saradar Patel University, Anand, Gujarat, India First Class
Bachelor of Pharmacy Aug2003-May2007

Coursework

• Pharmaceutical chemistry & applied biochemistry
• Pharmaceutical Engineering
• Pharmaceutical microbiology & biotechnology
• Pharmacology & Clinical pharmacy

References available up on request