Resume

Name: SANTHOSH SHENOY PRABHAKARA

E-Mail:acvsx6@r.postjobfree.com

ADDRESS: **** ****** ****

APT .18,SACRAMENTO 95834

CALIFORNIA

PHONE NUMBER:916-***-****

Educational Qualification:

COURSE

INSTITUTION

UNIVERSITY

DURATION

MARKS OBTAINED

%

B.PHARM

(Bachelor of pharmacy)

NGSMIPS

RGUHS, Mangalore

INDIA

2001

66%

M.PHARM

(Master of pharmacy)

(specialized in Pharmaceutical Chemistry)

NGSMIPS

RGUHS, Bangalore

INDIA

2004

75%

Degree / Certification

College/Institution/University

From

To

M.Pharm (Distinction)

NGSMIPS,Mangalore,Karnataka India

2002

2004

Professional Experience

Lotus Labs Pvt Ltd,

(Actavis+Watson Pharma) Bangalore, India.

Senior Executive (BA/BE Studies)

Apr-2013

Jan-2016

Lotus Labs Pvt Ltd,

(Actavis+Watson Pharma) Bangalore, India.

Research Scientist (BA/BE Studies)

May-2011

Apr-2013

Lotus Labs Pvt Ltd,

Bangalore, India.

Senior Chemist (BA/BE Studies)

May 2006

Apr-2011

Lotus Labs PvtLtd,Bangalore, India.

Chemist

Nov 2004

Apr2006

Crescent College of Pharmacy

India

Lecturer

Apr 2004

Oct 2004

Roles &Responsibilities

Acts as Project Leader for Good Laboratory Practices (GLP) BA/BE Studies

Analyzes samples as per various Regulatory Guidelines such asUSFDA, ANVISA, EMEA, WHO and CANADA under GLP environment.

Develops and validates new LC-MS/MS methods for the quantitation of drugs and their metabolites in biological samples.

Handling, Trouble Shoot & Calibration of Sophisticated Instruments.

Manages Sample inventory and Storage.

Prepares documents for Quality Control and Quality Assurance reviews.

Prepares and updates SOPs to Support Regulatory Environment.

Prepares Validation and Bioanalytical Reports.

Preparation and updating of BE Study Summary Report.

Preparation of Training materials and Conduct of in-house Training.

Review of BE Protocols according to Regulatory Guidance (EU, US, WHO & Canada).

Review of Chromatograms, Winnolinn data preparation,

Review of Complete Analytical Results.

Evaluation of Pilot study results for the initiation of Pivotal study.

Final Report Review.

Preparation of Standard Operating Procedures and Checklists.

Compilation of Regulatory Queries and Response.

Other Technical Skills

Performs routine maintenance of laboratory instruments.

Serves as System Administrator for laboratory instrumentations.

Identifies and maintains laboratory supplies.

Technology /

Instruments used

LCMS/MS : Series-4000, 3200, 3000, 2000 of API SCIEX and TQMS

HPLC : Agilent-1100,1200,1260 Series.UHPLC, Shimadzu,

Software : Analyst1.4.1, 1.6.2, Chemstation, SDMS, NugenesisWinNonlin.

Total years of Experience:

10+ years–Clinical-BA-BE studies(Regulatory)

Key Areas Of Expertise:BA-BE Studies, Clinical Research, Regulatory Affairs, QA & F&D,

Date : 07/11/16

Signature : Santhosh Shenoy Prabhakara

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