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Srinivas  J. | Elance
 
176985602337900
Last Sign-in: Dec 21, 2015

Srinivas J.

Quality Consultant
   India
Hyderabad
  |  7:15 pm Local Time

Overview

Quality Compliance for 21 CFR part 11, computer system validation (CSV).

GAMP 4/5, HIPPA. Internal auditor for CSV.

Certified Quality Consultanat, CMMI Consultant and ATM for CMMI appraisal ver 1.2, Certified Lead ISO 9001:2008 Auditor, ISO 27001 and implementor.

Quality Consultant (Chief Compliance Officer) for Software companies developing software for pharma companies (Clinical Trials)

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Aug 25, 2010|Other - Administrative Support|$100|Completed

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Skills (4)

Tested
Knowledge of ISO 9001 Test
My Score
avg
Process Compliance
21 CFR part 11 for CSV
CMMI

Service Description

21 CFR part 11 Compliance Management for Software companies developing Clinical devices.
CMMI process definition, implementation and training for appraisal
ISO 9001:2008 implementation for certification, ISO 27001:2005 defining, implementation and certification process CMMI ATM and consultant
Certified Lead Auditor
Internal Auditor, Trainer on quality SOPs and regulatiory gudelines

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Overview  |  Job History  |  Resume/C.V.

Keywords

21 CFR Part 11 Electronic Records & Electronic Signatures
CMMI
ISO 9001:2008
27001:2005
Regulatory compliance FDA
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Identity
Username
jaynisch
Type
Individual
Member Since
March 2010
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Srinivas  J. | Elance

Srinivas J.