Quality Control Medical

VISHAKHA R. PATEL

** ******** **.

Bethel, CT ***01

Cell Phone: 203-***-**** Home phone: 203-***-****

Linked In: http://www.linkedin.com/pub/vishakha-patel/26/412/38b Email: op9azx@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

More than 15 years in the pharmaceutical industry as a senior chemist in a Quality Control Laboratory. Analyzed more than 40 products (both tablets and capsules) in a timely.manner while maintaining a high level of quality. Provided guidance and assistance to both new and experienced chemists within the laboratory. Followed Test Methods, Standard Operating Procedures (SOP), General Testing Procedures (GTP), and General Laboratory practice (GLP) on a daily basis. Submitted change controls to Test Methods when needed.

• Excellent planning, organization, and time management skills

• Strong hands-on instrumentation

• Executes difficult analytical techniques and trouble-shooting instrumentation such as computer applications and programs related to laboratory applications (HPLC, UV-Visible, Dissolution, FTIR, TLC, Method Transfer and software such as Empower, LIMS, and JD Edward)

• Provides lead supervision and training to junior staff

• Experienced in Microsoft Word, Excel, and PowerPoint

PROFESSIONAL EXPERIENCE

WATSON LABORATORIES INC, Carmel, NY 2000-2010

Senior Chemist/ Team Leader

• Determined the accuracy of new test methods and procedures during the method transfers of new pharmaceutical products

• Tested in-process blends, process validation, finished-product/release, and stability testing of dosage forms as per the approved method

• Thoroughly performed audits/peer reviews within the HPLC workstation including Empower & LIMS

• Maintained and calibrated analytical instruments used for analysis, including HPLC, pH meters, balances, sonicators, dissolution units and glassware

• Trained new chemists on use of lab data collection systems such as Empower and LIMS

• Independently carried through on assignments for routine analysis, specifically Assay, Content Uniformity, Impurity/Degradant, and Dissolution Testing by HPLC & Dissolution Testing by UV; including all calculations associated with testing

• Completed work on all products with minimal supervision, on time or ahead of schedule, often working cooperatively with other chemists; willing to take on extra projects

• Resolved issues with HPLC units, troubleshooting system malfunctions, and making adjustments to the mobile phase to achieve system suitability requirements

• Maintained appropriate lab documentation as required by SOPs

• Participated as a member of Watson Behavioral Based Initiatives encouraging safety in the laboratory environment

• Verified expiration date of all reagents, standards, and instruments before performing tests

• Analyzed samples in accordance with all SOPs and GTPs, taking care to use the correct reagents and glassware required by the test method

• Worked with both Gradient & Isocratic HPLC methods, as well as normal and reverse phase

WATSON LABORATORIES INC, Carmel, NY

FORMER: SCHEIN PHARMACEUTICAL, Carmel, NY 1991-2000

Senior Chemist, 1999-2000

Chemist I, II, III, 1995-1999

• Analyzed all samples in accordance with SOP, GTP and test methods

• Determined the accuracy of testing during the method transfers

• Used the HPLC and UV units for assay, contents, and impurities

VISHAKHA R. PATEL op9azx@r.postjobfree.com Page 2

WATSON LABORATORIES INC, Carmel, NY

FORMER: SCHEIN PHARMACEUTICAL, Carmel, NY, continued

Tablet Technician, 1991-1994

• Compressed tablets in accordance with SOP, GTP and the given specification

• Inspect the tablets for weight, hardness, thickness, chipping, black spots and cracks

• Audited various paperwork

• Adjusted machines using the computer for weight, hardness and thickness

NATIONAL DAIRY DEVELOPMENT BOARD (NDDB), Anand, India 1983-1990

Microbiologist, 1987-1990

• Performed cultural and drug sensitivity testing of bacterial isolates

• Completed various biochemical tests for identification of various bacteria

• Prepared media, autoclaving, sterilization, etc.

• Processed frozen semen

• Conducted tissue culture work and performed various serological tests such as indirect haemagglutination tests, ager gel preparation of bacterial antigens

• Handled various sophisticated laboratory instruments

Clinical Pathologist, 1983-1987

• Prepared satin and staining procedure

• Processed clinical specimens like blood, blood smears, urine, feces for gastro-intestinal parasite, body fluid and skin-scraping for ectoparasite

• Conducted routine Hematology: blood cell count

• Analyzed Erthrocyte Indices: MCV, MCH, MCHC, MCD, Color Index, Erthrocyte-sedimentation Rate (ESR)

• Processed autopsy and post-mortem material for histopathological examination

EDUCATION

M.SC (Home) Foods & Nutrition, Sardar Patel University, India

B.SC (Home) Foods & Nutrition, Sardar Patel University, India

Medical Laboratory Technology, Bombay School of Medical Technology, Bombay, India

PUBLICATIONS

Patel, Vishakha; “A Comparative Study and Effect of Heating, Reheating and Frying Potato-Chips and Rice-Flakes on Physico-chemical Constants of Different Oil”; Department of Foods and Nutrition, Sardar Patel University, 1981

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