Quality Control Sales

Amit Narayan Khandagale

C-***, Vazira Riddhi Siddhi, Vazira, Borivali (W), Mumbai-400091

Nationality: Indian

****.**********@*****.*** Mobile No: +91-989*-***-***/ 8141

*** ***

OBJECTIVE

Business Development Manager determined to meet or exceed sales goals on

a consistent basis seeking a management position.

QUALIFICATIONS SUMMARY

. Driven to exceed expectations and willing to work efficiently and

effectively.

. Successful in communicating with people at all levels and with other

departments as needed to best serve the customer.

. Outstanding ability to professionally and effectively deliver

presentations to small and large groups.

EDUCATIONAL DETAILS

. M. Sc. (By Research) from University of Mumbai

. Bachelors in Science (Specialization in Chemistry) from D. G. Ruparel

College, Mumbai, India.

PROFESSIONAL EDUCATIONS

. Executive Program in Business Management (EPBM) from Indian Institute

of Management-Calcutta.

. 1 year certificate course in German language from University of

Mumbai.

PROFESSIONAL EXPERIENCE

Alembic Pharmaceuticals Ltd., Dec- 2013

till date

Alembic Road, Gorwa, Vadodara-393003, Gujarat

> Responsibility: Business Development Manager - Bioequivalence

V Job Profile:

. Explores and develops new research opportunities for Phase I

(Bioequivalence / Bioavailability) studies, Pharmacokinetics

studies and Clinical End point studies for Alembic.

. Evaluate new molecule potential in collaboration with other

internal departments.

. Keep up to date with any changes in the markets and the

regulatory legislation.

. Follow up on registrations and licenses.

. Performing complete Project Management activities for BA/ BE,

clinical end point studies

. Working with cross functional team

. Identifies, analyses and evaluates the current market trends and

recommends strategies to meet them.

. Develop strategic plan for business development for expanding

client base in India & Abroad.

. Develop an annual business plan for each existing and new

strategic account. Interact and coordinate with the strategic

business heads of relevant departments for development of

business.

. Preparation of Yearly Budget and monitoring the budget

parameters on quarterly Basis along with Project Execution,

Project Control and F&A representatives

. Establish and maintain account relationships and continuously

prospect for new opportunities through cold calling.

. Co-ordinate and execute presentations relative to company

capabilities and services.

. Maintain, manage and update business opportunities (RFPs, RFIs

and RFQs).

. Participate and represent the company in various trade shows,

industry conferences and other company business unit

sales/project management meetings.

. Travel nationally and internationally as required to present

company services.

SITEC LABS PVT. LTD.

June 2004-Dec 2013

PEE-DEE Infotech, Plot Gen 40, TTC, MIDC, Mahape, Navi Mumbai - 400701,

Maharashtra

> Responsibility: Business Development Executive

Nov 2009- Dec 2013

V Job Profile:

. Explores and develops new research opportunities for Phase I

(Bioequivalence / Bioavailability) studies and Pharmacokinetics

studies for Sitec.

. Responsible for achieving sales targets, preparing quotes and

contracts leading the bid defense process

. Identifies, analyses and evaluates the current market trends and

recommends strategies to meet them.

. Develop strategic plan for business development for expanding

client base in India & Abroad.

. Develop an annual business plan for each existing and new

strategic account. Interact and coordinate with the strategic

business heads of relevant departments for development of

business.

. Establish and maintain account relationships and continuously

prospect for new opportunities through cold calling.

. Co-ordinate and execute presentations relative to company

capabilities and services.

. Maintain, manage and update business opportunities (RFPs, RFIs

and RFQs).

. Participate and represent the company in various trade shows,

industry conferences and other company business unit

sales/project management meetings.

. Travel nationally and internationally as required to present

company services.

. Facilitate the administration and management of clinical studies

to ensure quality and timeliness in the conduct of clinical

trials.

> Responsibility: Senior Quality Control Executive

Nov 2007-Oct 2009

V Job Profile:

. Design Quality Control System for data analysis.

. Managed a team of 6 people assigning them tasks, and motivating

them to meet deadlines.

. Demonstrated the Quality Control procedures to sponsors and

regulatory authorities on Lab visits.

. Percentage of assessable subjects (No. of SOP, SAP, Protocol

Deviations).

> Responsibility: Quality Control Executive

Aug 2006-Nov 2007

V Job Profile:

. Conduction of Bioequivalence / Bioavailability studies as per

ICH GCP.

. Preparation of SOPs, checking of Protocols, CRF and ICF.

. Checking of pharmacokinetics and statistical calculation from

WinNolin and SAS software, checking of interim report, checking

of master binders, checking of draft and final reports.

. Maintaining the staff training records, training to staff,

conduction of internal and external audit.

. Documenting the adverse event reporting.

. Carrying out internal calibrations, conduction of assessments.

. 'Member Secretary' of Sitec Labs Institutional Review Board

(SLIRB). Organize meeting for SLIRB members, communicate with

SLIRB members and Sponsors.

> Responsibility: Clinical Research Associate

June 2004-Aug 2006

V Job Profile:

. Conduction of Bioequivalence / Bioavailability studies as per

ICH GCP.

. Preparation of Protocols, CRF and ICF for BA / BE studies,

preparation of BA / BE study report.

. Performing pharmacokinetics and statistical calculation on

WinNolin, calculation of number of subjects from SAS software.

. Checking of calibration report of instruments and equipments,

communication with Sponsors.

. 'Member Secretary' of Sitec Labs Institutional Review Board

(SLIRB). Organize meeting for SLIRB members, communicate with

SLIRB members and Sponsors.

TATA STEEL LTD., Dec

2001-Feb 2004

Datta Para Road, Borivali (E.) Mumbai-66

> Responsibility: Quality Analyzer (Quality Assurance

Department)

V Job profile:

. Preparation for ISO audits, Preparation of ISO related

documents.

. Chemical stock maintenance.

. Analysis of all metals by using different methods like

volumetric, electrolysis or using spectrophotometer.

COMPUTER SKILLS

. Strong Computer Skill: MS Office Suite, MS Project 2007

. Programming Languages: C/C++.

THESIS SUBMITTED

Screening And Standardisation Of Some Natural Product Used As Medicine In

Homoeopathy Using HPTLC Method.

RESEARCH PAPER PUBLISED

Screening and standardization of Adhatoda vasica used as medicine in

homoeopathy using HPTLC method, D. A. Shanbhag and A. N. Khandagale, Int.

J. Res. Pharm. Sci. Vol-1, Issue-3, 365-368, 2010.

Application of HPTLC in the Standardization of a Homoeopathic Mother

Tincture of Syzygium Jambolanum, D. A. Shanbhag and A. N. Khandagale, J.

Chem. Pharm. Res., 2011, 3(1):395-401.

Screening and standardisation of terminalia arjuna used as medicine in

homoeopathy using HPTLC method, D. A. Shanbhag and A. N. Khandagale,

International Journal of Analytical and Bioanalytical Chemistry 2011; 1

(3): 57-60.

Application of HPTLC in Standardisation of Homoeopathic Mother Tincture

Rauwolfia serpentina and its Comparison with Products in Market, D. A.

Shanbhag, S. Jayraman and A. N. Khandagale, International Journal of

Analytical and Bioanalytical Chemistry 2011; 1 (1) 13-18.

LANGUAGE

. Proficient in English, Hindi, Marathi, Gujarati.

SEMINAR ATTENDED and TRAINING GIVEN

Seminar on GCP: Seminar held at Medlar Laboratories in Aug. 2004 was given

by Dr. Harold Neil.

Seminar on GCP and GLP: Seminar held at Medlar Laboratories in Dec. 2004

was given by Mr. Chin Yoke Yue.

Seminar on Role and Responsibilities of Ethics Committee: Seminar held at

Sitec Labs in Nov. 2005 was given by Dr. Pratibha Worlikar.

Training Programme on Audits and Inspections: Seminar held at Cipla Ltd. in

March 2006 was given by Dr. Brengt Agrell (Sweden).

Seminar on Role and Responsibilities of Ethics Committee and GCP on 1st

March 2009 was given by Dr. Pratibha Worlikar.

Basic GCP workshop on 16th March 2011 was given by Dr. Rakhi Tripathi and

Dr. Nirmala Rege.

COMMUNITY INVOLVEMENT ACTIVITIES

. Member of Quality Circle in TATA Steel from 2002-2004.

. Member of Rotaract Club of Mumbai Kandivali-W (Dist. 3140) from 2004

- Jan 2007.

LEISURE ACTIVITIES

. Enjoy soccer, badminton, tennis, cricket and computer activities.

PASSPORT DETAILS

. Passport #: F3671846

. Expiry Date: 24/04/2015

Place:

Amit N. Khandagale Date:

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