Quality Control Data

Mahesh M. Dobariya

***, ******** ******, ****** ****, NJ 07307 Cell: 201-***-****, Email Id: **********@*****.***

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OBJECTIVE: Obtain a full time position in Analytical Research or Quality control area in pharmaceutical or biopharmaceutical industry.

SKILLS:

• Research and Analysis, Extraction, Titration, Knowledge about Wet-Chemistry (PH, Viscosity, Density, Turbidity, Moisture, etc)

• Chromatography and spectroscopic techniques.

• Knowledgeable in Chemical analysis, US FDA cGMP and SOP guidelines.

• Experience of working under cGMP/GLP environment.

• Well-versed in laboratory operations, equipment utilization, technical documentations, and reporting.

• Keen interest in Protein Chemistry, Biochemistry, Analytical Chemistry and Chemical Kinetic.

• Software Skills: ChemDraw, MS Office.

• SAS programming language (Data Analysis)

• Have been Computer Lab Assistant working on campus.

EDUCATION:

• MS in Pharmaceutical Chemistry, Fairleigh Dickinson University GPA: 3.41 (Dec 2011)

Coursework: Instrumental Analysis, Pharmaceutical Analysis, Pharmacokinetic, Chemical Kinetics, Protein Chemistry

Special Topics in Chemistry (Chromatography), Physical Pharmaceutics, Medicinal Chemistry, Organic Chemistry.

• BS in Pharmacy, Rajiv Gandhi University of Health & Science, Bangalore, Karnataka, India. (Oct 2008)

Coursework: Bio-Pharmaceutics, Pharmaceutical Technology, Therapeutic Drug Monitoring, Biochemistry, Medicinal

Chemistry, Pharmaceutics, Pharmacology, Hospital and Clinical Pharmacology.

EXPERIENCE: Alpha Analytical Laboratory; Mansfield, MA. March ’12-Present. Analytical Chemist

• Quality Control Data Review of Forensics, Sediments, Soils, Solids and Tissues to assist in the determination of ECO/Human Health Risk Assessments as a result of the BP Gulf Oil spill, along with other demanding industrial and commercial applications.

• Reviewing data quality records, calibration records, documentation of corrective action and other QA/ QC data.

• Performing Forensics analysis using analytical calculations according to project specific SOPs and QC criteria.

Torrent Pharmaceutical, India May’09 to Dec’ 09

Quality control chemist And Analytical Chemist Trainee

• Inspection of tablet for stability (Dissolution, Disintegration, and content uniformity test as per USP).

• Check Tablet specifications with standard data like loss on drying, friability, weight variation, as per USP/IP.

• Check physical and chemical properties of compound.

• Generated batch reports and discuss results of experiment with team leader.

• Testing of raw materials and related substance impurity test using UV Spectroscopy and compare with standard data.

Vasu Research Centre, India Nov’08 to Feb’09

Quality Control and Manufacturing Intern

• Performed analytical chemistry assays as per cGMP compliances based on new and existing methodologies.

• Operated analytical instruments such as HPLC, FT-IR and UV/VIS to analyze raw materials, production intermediates and final products.

• Perform quality tests by HPLC, GC/MS using calibration curve and documentation of results.

• Operated pH-meter, Karl-Fischer titrator and other techniques of wet chemistry.

• Reviewed and maintained batch records. Performed disintegration and dissolution testing of tablet and capsule dosage forms.

• Prepared and maintained laboratory documents under the regulatory compliance.

PRESENTATIONS / PARTICIPATIONS/PROJECT WORK:

• Presented a seminar on “Metal Organic Framework for HPLC Separation of ortho-Substituted Aromatics.”

• Presented a seminar on “Detectors used in HPLC.”

• Participated in national conference on role of traditional drugs and natural products in the management of Neurodegenerative Disorders.

• Separation of Compounds by Base Extraction. Steam Distillation of ingredient and Optical Activity. Synthesis, Analysis and Spectroscopy of a Metal Complex Compound. PH Titration and Gran Plot of a Weak Acid.

• Performed Identification tests, Purification and Synthesis of Organic Compounds.

References Available upon request.

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