Anita V. Patel

*** ****** ****** • Mount Kisco, NY 10549

914-***-****

cwaum9@r.postjobfree.com

SUMMARY

Auditor and Analyst with extensive experience with documentation and relevant experience with various chromatographic separation techniques and instrumentation. Worked effectively with members of other departments and functions to achieve cross-functional goals.

TECHNICAL & SPECIALIZED SKILLS

CGMP, LIMS, Trackwise, GXPharma, Totalchrom, Empower, TC Publisher Reports. Various Analytical Pharmaceutical Techniques.

HPLC HP 1090, HP 1050, Waters 2695 Separation Module, Waters 2487 Dual Absorbance Detector, Waters 486 Turnable Absorbance Detector, Hitachi pump

GC HP5890, HP 6890, HP Injector Model # 79855A

IC DX300, DX500 Dionex.

HPSEC Waters 712 wisp, Waters 590 HPLC pump, Waters 410 Differential Refractometer, Trisec, Wisp 710B, Hitachi and GBC pump, T50A Differential Refractometer

ANTEK Pyroluminescent Nitrogen and Sulfur, Infrared Spectrophotometer, UV/VIS Spectrophotometer

PROFESSIONAL EXPERIENCE

TEVA PHARMACEUTICAL INC. (formerly Barr), Pomona, NY 2003 - 2010

Auditor II

Audit data with Quality and compliance following SOPs, Methods, Rports, protocols etc. Quality audits by using software knowledge for chromatography data acquisition systems such as Totalchrom, Empower as well as LIMS. Raw Material Audits, Finished products Audits, Stability Audits, Metrology Audits,Method transfer Audits etc. Knowledge about Barr SOPs, Teva SOPs. Audits for chromatography such as GC, HPLC and other Techniques. Knowledge to interprete data with Quality and Compliance following FDA Rules and Regulations. Learn Trackwise software. Took some more Trainings related to Job Requirements. Became a Team player. Demonstrate resourcefullness and initiative in executing job functions, suggested process improvements and solutions and make decisions in Timely Manner.Openness to and able to manage changes in response to new challenges and opportunities. Continually search for ways to increase customer satisfaction and work diligently to shape the organization, resources and processes to strengthen relationships with customers and gain their loyalty.

• Avoided potential FDA citation by correcting Residual Solvents GC Method.

• Ensured accuracy of future products releases by correcting LIMS Templates.

• Participate actively in Quality Audits and suggestions for less deviations and better cycle time.

• Participate actively following CGMP, FDA Rules and Regulations and SOP-390 to close deviations successfully in LIMS.

• Ensured accuracy of Future products releases by correcting Totalchrom Methods for Standard amounts, Retention times, Relative retention times, Relative retention factors etc.

• Ensured accuracy of future products release by correcting TC Publisher Reports for functions such as Multiplies, Divisior, Area%, LC% etc.

• Ensured Qualily data by correcting Celsis Lab data for chromatographic calculations such as GC, HPLC and Atomic Absorption data.

• I have helped manufacturing department transfering methods, GMP work, Internal Audits, work as a Compliance specialist. Work closely with Quality Assurance and CGMP departments.

SAN-MAR LABORATORIES INC., Elmsford, NY 2000 - 2003

Quality Control Manager

Raw Material Analysis using USP NF, SOP, IR, UV / Vis, PH Meter, Balance, Bulk and Finished products Analysis using HPLC, GC.

• Generated additional revenue by Modification in Chloraseptic HPLC Analytical Method.

• Collaborated w/Taro Pharmaceutical Inc. by performing Method Transfer by HPLC in Benadryl cream successfully and improving extraction Method followed by HPLC Analysis.

• I have trained several people in instrumentation and software skills. I trained new hires in various areas.

• I used to take care of Batch Record Review and write reports. I was documentation person. I handled FDA and EPA inspections.

CYTEC INDUSTRIES INC., Stamford, CT 1991 - 2000

Chemist

• HPLC, GC, HPSEC, and IC data with excellent turnaround time to key customers by using automated calculation method for PE NELSON data acquisition system resulting in time saving to the company.

• Improved purity correction 3% using HPLC Analytical Method brought up the yield for the product resulted in revenue to the company. (UV5411, UV2337 Projects.)

A CHOCOLATIERE, Poughkeepsie, NY 1988 - 1991

Manager

Owned and operated family owned store.

LABS AND RESEARCH, Valhalla, NY 1985 - 1988

Assistant Environmental Chemist

Analyzed aromatic hydrocarbons by PID, Halogenated Hydrocarbons by HALL and PNA by HPLC by using EPA methods.

• Set up an Automated Purge and Trap system for PID and HALL Detector saving time and money to the company.

• Passed NY State Exam for Assistant Environmental Chemist.

EDUCATION

Master of Science in Chemistry, Gujarat University, India

Accredited by International Education Research Foundation, Inc. California.

Associate Degree in Computer Science, Westchester Business Institute, White Plains, NY

PROFESSIONAL DEVELOPMENT

Skills: Total Chrom, Empower, PE NELSON data acquisition system, Microsoft Word, Dionex Peaknet chromatography workstation, Excel, Millenium Software. HPLC Method development - LC Resources, Theory and practice of SEC - Waters, Triple Detection - Viscotek, Ion chromatography Theory and Troubleshooting - Dionex.

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