Chemist,QA, Project manager

Gita Patel

* ******** ***** ******, ** ***** **********@*****.*** 845-***-****

Highly motivated and effective QA Professional dedicated to giving 100% on all jobs. Extensive experience in the inspection of raw material, in-process and stability sampling, issuance of Manufacturing Batch Records, and knowledge of GLP and cGMPs. Strong analytical ability and comfortable working in wide variety of environments

Education

Two year AAS Arts and Sciences Dabhoi Commerce College - Dabhoi, Gujarat. India

Work History

Teva Pharmaceuticals Inc. - Woodcliff lake NJ 1989- 2009

QA Associate

QA Inspector for Manufacturing and Packaging Operations.

Effectively managed multiple projects and easily shifted to other projects when needed.

Focused on Issuance of Manufacturing Batch records, sample raw material, review of laboratory test reports for finished products, intermediate, in- house standards, cleaning validation reports and instruments calibration data.

Inspected compounding operation, blend sampling, tableting, encapsulation, and coating.

Performed in house audit on the manufacturing floor.

Filled in requests for documentation from other departments required from the filing area and coordinated all relevant activities.

Accurately and properly followed procedures, and worked with word, and excel programs.

Performed data entry, reviewed and audited manufacturing and packaging batch records.

Review final printed labeling components for release into inventory

Performed proof review of label and labeling materials.

Have experience in reviewing regulatory documentation pertaining to ANDA submissions for labeling revision verification.

Par Pharmaceuticals - Chestnut Ridge, NY 1987-1989

QA Coordinator (1988-1989)

Prepared and distributed batch records as issued to the proper customers as required

QA Inspector (1987-1888)

Performed in process visual inspection of products.

Performed and prepared certificate of compliance statements, product labeling and final packaging for shipment

Professional Accomplishments

Trained in SAP programming in associate management.

Familiar with LIMS.

DEA Certification obtained

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