MS in Industrial Pharmacy with work experience in QA, QC, production.

P riyanka Pathak

Tel # 347-***-****, E-mail: accauc@r.postjobfree.com

Address:

** ***** **** ******, **** 2, Andover, MA 01810

Objectives:

To excel as a professional in Industrial Pharmacy with dedicated efforts and innovative thinking for companies growth

and self improvement.

Summary:

Masters of Science (M.S.) in Industrial Pharmacy with experience in Quality Control (QC), Production and

pharmacovigilance.

Awareness regarding current Good Manufacturing Practice (cGMP), Current Good Laboratory Practices

(cGLP), International Conference on Harmonization (ICH) guidelines and 21 CFR.

Sound knowledge of production process in the area of solid, semi-solid and liquid dosage form.

Good understanding of raw material and its composition in development of pharmaceutical, cosmetics and

toiletry product.

Theoretical understanding of aerosol formulation and consumer dermatological product formulation.

Familiar with Spontaneous post-marketing surveillance with respect to drug safety.

Able to work independently and a good team player with good written and communication skills.

Ability to follow and execute the given task accurately and solve problems with creativity.

Skills:

TLC, HPLC, Titrations, Dissolution, Extractions, Karl Fischer, UV/VIS Spectroscopy, IR and FTIR

Spectroscopy.

Helped develop SOP, writing of protocols for analytical method and validation, create release of electronic

documents and records according to 21 CFR Part 11, review manufacturing batch records according to

cGMP requirements; aware about validation lifecycle (testing IQ,OQ,PQ).

Formulation of pharmaceuticals products, physical testing of finished products (sieve analysis, friability,

disintegration, hardness, moisture determination)

Excellent understand of Microsoft Office (Word, Power point, Excel, Outlook), Argus Safety software,

Sebel Data Analysis Software; Can utilize MedDRA and MedWatch; Basics of SQL queries.

Experiences:

Kabco Pharmacuticals, Long Island, NY

Chemical Technician August 2013 - December 2013

Preparing, running and analyzing raw material, stability, in process and finished product samples for the QC

lab with the use of Nanodrop Machine.

Carry out potency calculation in the excel sheets for HPLC related chromatograms and cross check with the

Certificate of Analysis (COA) specifications.

Perform dissolution, disintegration, friability, hardness, and weight variation tests on the finished products.

Carry out vendor qualification and standard qualification of all the raw materials which are been used in the

company and make in house reference standard (secondary reference standards) for comparative study.

Help in the release of the raw materials and create electronic records according to 21 CFR specifications.

Keeping a detailed lab notebook and inputting data into the database.

Helped writing Standard Operating Procedures (SOP)

Long Island University, NY

M.S. in Industrial Pharmacy (Pharmaceutics) September 2011 – May 2013

Bio-analytical method validation of pharmaceutical drug with the help of HPLC.

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P riyanka Pathak

Tel # 347-***-****, E-mail: accauc@r.postjobfree.com

Present Address: Permanent Address:

107-63, 100th Street, Ozone Park, New York, NY 11417 72 North Main Street, Unit 2, Andover, MA 01810

Seminar Presentation: Nutricosmetics – Beauty and wellbeing from inside

Paper presentation:

• Sunscreen formulations

• Silicone- A future ingredient in Cosmetics Industry

Cognizant Technology Solutions’, Mumbai (India)

Jr. Data Analyst (Pfizer Pharmacovigilance department) February 2011 - July 2011

Spontaneous post-marketing surveillance of Pfizer Medicines and Wyeth OTC products.

Receive and accurately document Adverse Event (AE), Product Complaint (PC) and Medical Inquiries (MI)

from patients and Health Care Professionals on safety CRFs (Case Report Forms).

Perform safety data entry in the database, coding relevant medical terminology, writing descript narratives,

generating queries pertinent to the case, performing quality control and ensure case reporting using medical

dictionaries like MedDRA and MedWatch.

Creating an electronic case report file for a new case with respect to 21 CFR Part 11 and then submit it to

client.

Carry out triage of the case and seriousness of the case with respect to its AE.

Preparing a case file for a patient who has experienced any adverse effect after any Pfizer medications with

the use of Siebel and Argus Softwares.

Dr. Kiran Pathak Ayurvedic Clinic, Solapur, India

Formulator August 2010- September 2010

Acquired knowledge of small scale commercial production of cosmetics product like shampoos, herbal face

masks etc.

Prepared healing balms and aroma oils with the help of formula provided.

Improved my knowledge in herbal product development.

Meyer Organics Pvt. Ltd., Thane, India

Trainee June 2009

Worked on different chromatographic methods like Thin Layer Chromatography (TLC) and High

Performance Liquid Chromatography (HPLC) in its Analytical Department. Basic understanding of Visible

and Ultraviolet Spectroscopy.

Performed assay with different titration methods and dissolution tests on raw material, in process material and

finished products according to the companies SOP under GLP.

Observed the process of making SOP and validation reports in the analytical department.

Learnt different methods of evaluation of tablets and capsules and understood the basics of batch

manufacturing including ANDA in production department.

Understood the basics of batch manufacturing process with respect to cGMP.

Mumbai (Bombay) University, Mumbai, India

B. Pharmacy June 2006- July 2010

Seminar: Prolotherapy: A Solution for Pain

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P riyanka Pathak

Tel # 347-***-****, E-mail: accauc@r.postjobfree.com

Present Address: Permanent Address:

107-63, 100th Street, Ozone Park, New York, NY 11417 72 North Main Street, Unit 2, Andover, MA 01810

The treatment causes the proliferation (growth and formation) of new ligament tissue and tendons in areas

where it has become weak. It is a non-surgical, natural healing technique in which ligament reconstruction

occurs for chronic and other different types of pain.

Project presentation: “IV Young Pharmacists Innovative Project Award”. The Group formulated a product

named as “VariCigg” which helps a smoker to quit smoking. Smokers will easily familiarize themselves to

the therapy as the withdrawal drug is in a cigarette form. In the therapy, a smoker’s intake puffs with

specially-designed dose regimen containing Varenicline giving the cessation effect through partial nicotine

replacement and helps the smoker to quit smoking.

Educational Records:

M.S. in Industrial Pharmacy (September 2011- May 2013) from Long Island University, NY.

B in Pharmacy (June 2006 – July 2010) from Mumbai (Bombay) University, Mumbai, India.

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