Quality Control Six Sigma

Arpita Patel

** ********* ******

Jersey City, NJ-07307

Cell: 201-***-****

**********@*****.***

OBJECTIVE: Looking for an opportunity in a pharmaceutical firm where I

can expose my knowledge and gain some experience to build my

career.

EDUCATION: M.S. in Pharmaceutical Engineering:

GPA-3.5/4.0

(New Jersey Institute of technology)

Major subjects : Principles of Pharmaceutical Engineering,

Validation and regulatory Issues in the Pharmaceutical

Industry, Pharmaceutical unit operations( liquid and

dispersed phase systems), Solids processing, Principles of

Pharmacokinetics and drug delivery, Pharmaceutical facility

design, Pharmaceutical Packaging technology, Industrial

quality control, Organizational behavior

Presentations in M.S.

. Powder Coating

. Parenteral Packaging -concerns of biotech drugs

. Six sigma approach

. Powder blending and its types

B.S (Pharmacy)

GPA 3.7/4.0

(Sardar Patel University, India)

Major subjects: Microbiology, human anatomy, Pharmacology,

Biochemistry, Analytical chemistry, Dosage Form Design,

Pharmaceutics, Pharmacognosy, Medicinal Chemistry etc.

Experiments: TLC, UV/VIS, HPLC, Chromatography, Analytical

Experiments, etc.

SKILLS: Lab Skills: Titration, Assay Analysis,

Chromatography and Chemical Solution

Preparation, Quality tests of pharmaceutical

dosage forms, etc.

I have knowledge and experience of cGMP/GLP

regulations.

EXPERIENCE: Lincoln Pharmaceuticals Ltd., India (april 2007 - may

2008)

. Manage compliance activities with all regulatory

agencies (FDA, CAP, etc)

. Package design, packaging development, performance

testing, troubleshooting and optimization

. Develop assay and instrument qualification activities

including the design and implementation of assay

variability criteria

. Knowledge of FDA and EU regulations

. Review batch records. Perform incremental approval of

batch records

. Perform AQL evaluations and in-process physical testing

. Evaluate manufacturing support areas such as the

warehouse for compliance with cGMPs as described in

SOPs

. Performed experiments with HPLC,GC,DISSOLUTION, TLC and

UV/VIS

. Chemical solution preparations and perform titration and

assay analysis

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