Job Seeker

Name: SANTHOSH SHENOY PRABHAKARA

E-Mail:acyth1@r.postjobfree.com

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

APT 18,SACRAMENTO 95834

CALIFORNIA

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

Educational Qualification:

Bachelor of Pharmacy,India

Master in Pharmaceutical Chemistry,India

Professional Experience

Lotus Labs Pvt Ltd,

Senior Executive (BA/BE Studies)

(Actavis+Watson Pharma) Bangalore, India.

Lotus Labs Pvt Ltd,

Research Scientist (BA/BE Studies)

(Actavis+Watson Pharma) Bangalore, India.

Lotus Labs Pvt Ltd, Senior Chemist (BA/BE Studies)

Bangalore, India.

Chemist

Lotus Labs PvtLtd,Bangalore, India.

Crescent College of Pharmacy

Lecturer

India

Acts as Project Leader for Good Laboratory Practices (GLP) B

Analyzes samples as per various Regulatory Guidelines such

Roles &Responsibilities

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Develops and validates new LC-MS/MS methods for the quan

Handling, Trouble Shoot & Calibration of Sophisticated Instru

Manages Sample inventory and Storage.

Prepares documents for Quality Control and Quality Assuranc

Prepares and updates SOPs to Support Regulatory Environme

Prepares Validation and Bioanalytical Reports.

Preparation and updating of BE Study Summary Report.

Preparation of Training materials and Conduct of in-house Tra

Review of BE Protocols according to Regulatory Guidance (E

Review of Chromatograms, Winnolinn data preparation,

Review of Complete Analytical Results.

Evaluation of Pilot study results for the initiation of Pivotal st

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 instrumentation

Identifies and maintains laboratory supplies.

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

Technology /

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

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

Total years of Experience:

10+ yearsBioanalytical-Clinical-BA-BE studies(Regulatory)

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

Date : 01/20/2017

Signature : Santhosh Shenoy Prabhakara

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