Quality Control Raw Materials

Anelia Grozeva

Cell: 914-***-****

Scarsdale, NY Home:914-***-****

*****.*******@*****.*** https://www.linkedin.com/in/aneliagrozeva

Summary Qualifications

Senior Level Analytical Chemist and Quality Control professional with over fifteen years of experience in the pharmaceutical industry.

Very well organized, self motivated, details oriented, hardworking and knowledgeable.

A team player, with strong troubleshooting, coordinating and decision making skills and a commitment to accept all challenges

Extensive skills and knowledge in laboratory testing of finished product, Stability testing and study, intermediate and in process products utilizing analytical techniques and instrumentation following cGMP, GLP and company guideline.

Extensive experience in analytical chemistry, chromatographic methods of analysis..

Familiar with USP, FDA and ICH guidelines.

Expert in HPLC and UPLC, GC, CE, UV/VIS, FTIR, KF.

Specialties: Empower, Totalchrom, Karat-32, TLC, Melting point, TLC, Laboratory protocols, Reports an SOPs, CAPA, Investigations Root cause analyses and audits.

Skilled in Computer programs including SAP, LIMS, MS Excel, MS Word.

PROFESSIONAL EXPERIENCE

Novartis Pharmaceuticals., Suffern, NY 2005 – 2015

Sr. Scientist

Conducted analysis of finished and stability products, with various laboratory procedure s/techniques and in accordance with regulations.

Conduct Assay, Impurity, CU, Dissolution and Dissolution profile, ID, Water determination by KF, hardness, disintegration tests.

Conduct complete stability testing and test methods.

Performed testing of control drugs class 2.

Receive, test and evaluate customer complaint samples; conduct and write investigation for Out of Specification (OOS) and Out of Expectations (OOE) results & complaints samples.

Participated in the investigation of abnormal and OOS test results and equipment failures which included determining cause, corrective action/preventative action (CAPA) and writing the investigation report.

Supported process validation and method transfer.

Validate analytical procedures and reports as per SOP's to meet assigned due dates.

Audit the work of other scientists, as assigned, to ensure accuracy, completeness and compliance with departmental SOP’s

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Barr Laboratories, Pomona, NY 2001 - 2005

Analytical Chemist

Completed analysis of in-process samples and finished products in accordance with USP, NF, FDA regulation.

Performed complete stability testing of raw materials, finished, control drugs-class 2 and 3 and in process products.

Performed dissolution, assay, impurity and related compounds and Content uniformity, water determination by KF, melting point tests.

Performed cleaning validation samples analysis.

Performed and support method validation and method transfer tests.

Supported instrumental calibration-HPLC, GC and Capillary Electrophoresis.

Bristol-Myers Squibb-Clairol Inc., Stamford, CT 2000 - 2001

Chemist(on contract assignment)

New Products Development – Pre-formulation study of Hair Dye Products. Preparing batches of hair color products.

Monitor action of dye formation for researching new hair dye products and purification of synthesized products.

Optimize formulation by using new alkalizes.

Performed routine chemical analyses, stability and physical testing of different hair products using UV, and other analytical methods like TLC, Colorimetric analyses, etc. Matching color of hair products.

Experienced on performing wet analysis including titration and extraction.

Purdue Pharma Laboratories, Ardsley, NY 2000

Chemist- On contract assignment

Supported the development of new analytical test methods - assays, impurities and dissolution tests. Performed analytical testing of finished products by USP/NF methodologies.

Early career experience in Bulgaria included work as a Chemist in an academic institution and a pharmaceutical company.

Performed Qualitative and Quantitative analyses of pharmaceutical and herbal products

- Raw materials and finished products.

Analyzed, researched and developed natural organic products - isolation, separation and

Determination of the structure and the chemical properties of organic active compounds

of herbs, used as active ingredients in the pharmaceutical and cosmetic products.

Performed chromatographic analyses- HPLC, GC Column and TLC and analyzed

chromatograms. Used IR and UV-VIS for spectral analyses.

EDUCATION

Certificate in Industrial pharmaceutical technology, Seneca College, Toronto, Canada

Master’s Degree in Chemistry, University of Sofia, Sofia, Bulgaria

Thesis Research: Phytochemical investigation on Alkaloid composition from Thalictrum minus /Isolation and identification of Alkaloids/.

Technician/Technologist Diploma, Technical College Of Industrial Chemistry, Sofia, Bulgaria

LANGUAGES

English, Bulgarian and Russian

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