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BALAJI . Kulandaivelu | Elance
 
176985602337900
Last Sign-in: Mar 23, 2015

BALAJI . Kulandaivelu

   India
  |   Bangalore, Karnataka

Overview

Overall 14 years of immense experience in Pharmaceutical Quality Managements Systems, Corporate Quality Systems implementations, and inlcudes
Expertise International Lead auditor for Due diligence, Mock, For-cause audits for Sterile/Non-sterile API, formulations & biopharmaceutics & its related containment, safety requirements for various regulated markets
Subject Matter Experts for implementing and harmonizing a corporate structure in overall Quality systems.
Expertise decision-maker on product quality for overall product life cycle...

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Skills (10)

Tested
Nanomedicine
Aseptic Processing
Quality Management
Microbiology
Compliance Audits
Taekwondo - My Love
Sterile Validations
V&V
Quality Auditing
GLP

Employment

Xellia Pharmaceuticals
Global Head Corporate Quality
2011 - Present
Subject Matter Expert for Quality system for overall product life cycle management for Xellia and CMO operations. Reviewing, improving and harmonization of Corporate Q related SOPs; Supporting Q...
Orchid Pharma (currently Hospira)
Senior Executive - Audit & Compliance
2003 - 2009
Experienced in Microbiological qualification from Initial qualification till commericial production of Ceph, Betalactam and Meropenem formulation manufacturing facility, Faced FDA, MHRA, MCC,...
Mount Mettur Pharma, Chennai
QC Analyst
1999 - 2001
Performing QC testing and analyses.

Education

Vellore Institute of Technology
Ph.D
-
University of Madras
M.Sc
-
Loyola institute of Business Administration
MBA
-
Overview  |  Job History  |  Resume/C.V.

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Identity
Username
nanobalajik
Type
Individual
Member Since
March 2015
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BALAJI . Kulandaivelu | Elance

BALAJI . Kulandaivelu