Analytical method development, validation, deficiency response

RESUME

Dr. SHEFALI PHADATARE

Permanent Address:-

Kumar Papillon, Bldg – A1, flat – 801,

Behind Abhinav Art College,

Pashan-Sus Rd., Pashan,

Pune - 411021. (MAH), INDIA

Phone (Res.): +91-976*******/ 915-***-****

E-mail: *******.*********@*****.***, ***************@**********.***

ACS membership No.: 31314527

Fourteen years of experience in R& D (Analytical support to Formulation-Injectables).

Core responsibilities:

Lead and manage the R&D projects within defined parameters

Effective resource utilization, time management & cost control

Technical support to plant, regulatory dept and other stack holders

People management – Team, vendors, internal and external customers

Achievements:

10 projects successfully completed for Europe & US market

Developed the deactivation method for carcinogenic compound. Helped us to reduce outsource expenditure

British pharmacopoeia revised product monograph based on my research inputs

Educational qualification:

Doctorate in Analytical Chemistry, 21st July 2001 (submission date), awarded in the year 2002 Rani Durgavati University, Jabalpur (M.P), INDIA

Publications:-

Solid-phase extraction and spectrophotometric determination of chlorine in air and residuals of free and combined chlorine in water utilizing azo dye formation, M. Pandey, S. Gosain, B. Sahasrabuddey and K.K. Verma, The analyst, 123, 2319 (1998)

Solid-phase extraction and spectrophotometric determination of iodate in table salt utilizing azo dye formation, S. Gosain, M. Pandey, and K.K. Verma, J. Assoc. Off. Anal. Chem. Int. 82, 167 (1999).

Solid-phase extraction and spectrophotometric determination of hydrogen sulphide in air and water utilizing Ethylene blue formation, V. Singh, S. Gosain, S. Mishra, A. Jain and K.K. Verma, The Analyst, 125, 1185 (2000).

Determination of Bromide in fumigated and natural sample by conversion into bromo-phenols followed by gas-chromatography-mass-spectrometry, S. Mishra, S. Gosain, A. Jain, K.K.Verma. Anal Chim Acta, 439, 115 (2001).

Master of Science (Organic Chemistry) in 1996

Bachelor of Science in 1994

Kindly note in all above publications my name reflects as S. Gosain (Before marriage name.)

Chronology of Experience:-

Position & Organization

Period

Experience summary

Sr.Research Scientist, (M03) Emcure pharmaceutical LTD, PUNE.

From Jan 2009 to till date

- Leading a team of 6 people to achieve targets.

- Analytical method development & method validation for generic products (Injectables for Europe market as per ICH guidelines)

- Technology transfer of analytical methods to QC.

- Preparation of SOPs and specifications of drug substance, drug product and excipients.

- Experience in responding the deficiencies points received after drug product submissions.

- Theoretical knowledge of leachable & extractable.

Grade E2, Analyst,

USV Pharmaceuticals Ltd, Govandi, Mumbai.

February 2007 to October 2007 & From February 2008 –Dec -2008

- Mentored a team of 4 people for analytical method development, stability analysis.

- Analytical method development & method validation for generic products for Europe market products as per ICH guideline

- Hand on experience on LIMS (Laboratory Information management System) for master creation for stability data.

Sr. Analytical Scientist II, Novartis India Ltd.

Thane, Mumbai

October 2005 to February 2007

-Experience of setting new analytical laboratory.

-Known to IQ,OQ & PQ of new Instruments

(Waters HPLC’s, Agilent 6890 GC-FID with headspace, Perkin Elmer FTIR, Perkin Elmer Atomic absorption spectrophotometer and Lab India dissolution machines.)

-Preparation of instrumental operation, analytical and cGMP/GLP SOPs, IQ, OQ, PQ protocols.

-On going work includes preparation of stability SOP like Stability plan, stability reports.

-Preparation of QSR for the instruments

Research associate-I, Lupin Research park, (Lupin Pharmaceuticals Ltd.) (US FDA approved company)

From February 2004 to October 2005

- Analytical Method development (for Three ANDA projects) on Immediate & controlled release solid dosage forms.

- Analytical Method development for Five ANDA project under developmental stage.

-Preparation analytical method development report.

-Coordinating with R&D and quality assurance

during method transfer.

- Hands on experience on advanced equipments: Thermo-separation, Hewlett-Packard, Agilent, Waters & Shimazdu HPLC systems with respective advanced soft wares. Hewlett-Packard GC-MS (5890) and GC-FID (6890), Dissolution machines (Electrolab & Labindia)

Research Scientist-II Emcure Pharmaceuticals Ltd, Pune, India.

From April 2002 to February 2004

-Method development and validation for nine products.

–Documentation of method development and validation data for nine products.

Research Experience:-

Position & Organization

Period

Research Experience

Senior Research Fellow, (Extended), Rani Durgavati University, India.

From 31-03-01 to 31-03-02

- Solid phase micro extraction for analysis of polar pesticide, drugs and their decomposition product by GC – MS.

Senior Research Fellow, Rani Durgavati University, India.

From 01-04-99 to 31-03-01

-Solid phase extraction of organic micro-pollutants from environmental waters and pharmaceutical drugs for their analysis by High Performance Liquid Chromatography

Junior Research Fellow

Rani Durgavati University, India

From 01-09-96 to 01-12-98

-Solid phase extraction of semi volatile compounds from environmental waters and pharmaceutical drugs for their analysis by High Performance Liquid Chromatography.

Computer skills:

Proficiency in MS-office, Chemwind, Empower, Agilent, Chromleon, LC solutions,

Languages known:

English (Read, write & speak)

IELTS (International English Language Testing System) – Certification done.

Personal Details:

Passport details: M0609139 Valid till Aug 2024

Nationality: Indian

Place: Pune, INDIA

Date: 24-09-2017

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