Sagar J Patel

*-* * **** **, Norwich, NY ***** PH: 607-***-****

acgcrc@r.postjobfree.com

Overview:

Quality Control / Quality Assurance professional, seeking a position in

Pharmaceutical industry to utilize training and develop skills to achieve

company goals. Strong interpersonal skills of problem-solving and decision

-making. Pharmaceutical expertise with relevant qualifications plus hands

on experience in Analytical method validation, Stability studies, In-

process and release studies, analytical investigation with trouble

shooting, method transfer and analytical training.

SKILLS:

Software: Total Chrome, MS Word, MS Excel and MS Power Point

Analytical:

. Operated, calibrated automatic and repeater pipette, analytical

balance in QC laboratory.

. Assessed Identification and Assay Determination of Calcium Chloride,

Magnesium Phosphate, Cupric Sulfate and identify the various sources

of testing errors.

. Performed limit tests for raw materials and performed titration for

raw material assay.

. Operated ion selective electrode to determine ions in raw materials.

. Performed titration and chromatography (TLC, HPLC, and GC).

. Interpreted pharmacopoeia guidelines to perform testing of raw

materials, in-process materials, and finished pharmaceutical products.

. Operated, calibrated pH Meter Orion 330and conductivity meter, Oakton

CON 510 to measure pH of prepared solutions.

. Operated UV/Vis Spectrophotometer, shimadzu UV 1700 to quantify

elements in sample.

. Assessed and troubleshoot analytical equipment failure and instrument

malfunction in compliance with regulatory requirements.

. Operated Perkin Elmer Fourier Transform Infrared Radiation (FTIR)

Instrument.

. Familiarized with Atomic Absorption Spectrophotometer (AAS). Operated

AAS to evaluate copper in Cupric Chloride Injection.

Quality Assurance:

. Applied Good Manufacturing Practices (GMP) and (GDP), Training,

Investigations in Pharmaceutical Industry as per US and Canadian

regulations.

. Performed a variety of Quality Assurance Operations including

developing QC documents, QC audits, QC policies, and Standard

Operation Procedures.

. Identified laboratory hazards and deviations or errors and took the

required corrective actions.

. Laboratory Proficiency: Expertise with assay, related compounds,

dissolution, content and blend uniformity, friability, hardness, PSD,

powder flow property, bulk/tap density,TLC, AA and pH studies; Lab

scale manufacturing of tablet, suppositories, cream and ointment;

Qualitative and quantitative analysis of chemical compound.

Regulation & Research Activities:

. Experienced of cGMP, GLP, FDA and ICH guidelines.

. Novel Drug Delivery Systems and Process variables. Identified Types

and Mechanisms of drug delivery systems, Market survey.

. IQ and OQ protocol preparation for Friability Tester machine.

Personnel Skills: Excellent writing and communication, self-learner and

researcher, Self-initiative and motivated, timeline oriented, management of

team, strong knowledge of good documentation practice.

EXPERIENCE:

R.W Packaging, Winnipeg, MB

Nov 2012 -

Aug 2014

Quality Control Analyst (Practicum)

. Assessed quality of raw materials and in-process materials.

. Checked quality of parental products with their specifications.

. Maintained clean and sanitary condition in QC labs.

. Generated and preserved data according to GDP.

. Presented and attended seminars on quality review.

. Prepared and conducted internal and external audits and helped prepare

for a regulatory inspection.

. Followed the cGMP regulations and performed Quality Control (QC)

testing on tablets.

. Executed analytical methods of pharmaceutical solid dosage forms

especially for assay, content/ blend uniformity, dissolution and

identification.

. Worked in a team environment to undertake physical tests on tablets

and capsules.

. Performed accurate and timely analysis of release and pre-approved

stability samples.

. Exercised particle size distribution, bulk and tap density with powder

flow property for experimental and final batches.

. Performed technology transfer of analytical method between R&D and QC

department.

. Prepared and reviewed stability tables, data trending, certificate of

analysis and final reports.

. Recorded, evaluated, interpreted and summarized technical data

independently.

. Presented analytical data from internal and external sources, and

prepared reports for product release.

. Provided hands on training to coworkers and trainees regarding

Instrument operation and analytical testing.

. Independently manage products starting from experimental batches,

feasibility studies, protocol testing, release and stability testing.

. Arranged group meetings to develop project design, route cause

analysis and weekly reports.

. Initiated change control to method and procedures requiring

modification.

. Reviewed routine bench work, laboratory notebooks and logbooks. .

. Assisted in maintaining laboratory equipment, supplies and facilities.

Rani Chennamma College of Pharmacy, Belgaum, India

Dec 2008 - Nov 2011

Laboratory Research Assistant (Practicum)

. Worked as laboratory assistant with college professor in finding anti-

Convulsant activity in citrus fruits.

. Performed variety of Chemical tests, Carried out various assays and

analytical tests.

. Documented data as per GDP and followed GLP.

. Prepared and maintain various solution used in testing.

. Performed Gas chromatography, HPLC, TLC, FID Specifications.

. Learned and executed different aspects in tablet manufacturing

including granulation, compression, coating and packaging.

. Executed analytical method validations of analytical method of Assay,

Dissolution of finished products.

. Performed assay purity testing for APIs.

. Participated in technical method transfer and training to Quality

Control.

. Managed whole laboratory for inventories and supplies of chemicals and

reagents.

EDUCATION:

Red River College, Winnipeg, Manitoba

Post-Graduation in QA/QC (April 2013)

Major: Quality Control/ Quality Assurance

Relevant course work:

. The concept of quality assurance in a manufacturing environment that

is controlled by good manufacturing practices, quality systems, and

regulatory agencies.

. Documentation, Validation, Deviations, Corrective and preventative

actions, Auditing, Inspection.

Rajiv Gandhi University of Health Sciences, India

Bachelor in Pharmacy (Aug 2007- Nov 2011)

Relevant course work:

. Theoretical knowledge of analytical tests in pharmaceutical industry

and performed various analytical tests on APIs and finished

pharmaceutical products by chromatography, spectroscopy and titration

methods.

. Formulated and Analyzed pharmaceutical dosage forms. Gained knowledge

of Pharmaceutical Organic and Inorganic chemistry, Medicinal

Chemistry, Pharmaceutical Microbiology and Biotechnology, Applied

Biochemistry, Pharmacology.

. Gained fundamentals of Pharmacology and performed toxicology studies

on animals.

Certificates: WHMIS Certified.

REFERENCES: Available on request.

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