CURRICULUM VITAE

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QUALITY & VALIDATION MANAGEMENT PROFESSIONAL
expertise
services

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projects
audits

about
D.Ramesh Babu
Independent Pharma Consultant
Commissioning, Qualification, Validation
Quality Management System
drameshglobal@gmail.com
+91-7032597309/8247899827
 2017 2014 2013
1 2 3
expertise
services

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LEAD HEAD HEAD
CONSULTANT Quality Quality
Commissioning & Assurance/ Assurance/
Qualification Validation Validation
Givaudan – GMP Cadila Pharma Akums Pharma
Pfizer – Sterile
Systacare – Sterile
Prime Bio - Sterile
 2013 2012 2011
4 5 6
expertise
services

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projects
audits

about
HEAD Sr. MANAGER Sr. MANAGER
Quality Corporate Quality Validation
Assurance/ Assurance Consultant
Validation Sterile Divisions Solid & Liquid
Human Vaccines Aurobindo Pharma Orals
Indian Adcock Ingram
Immunologicals
 2010 2009 2008
7 8 9
expertise
services

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projects

2
audits

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MANAGER Dy.MANAGER Sr.EXECUTIVE
Quality Assurance Quality Commissioning,
(Validation) Assurance/ Qualification &
Human Vaccines Validation Validation
Biological E Ltd. Biologicals Reliance Life
Syngene(Biocon) Sciences
 2006 2004 1998
10 11 12
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EXECUTIVE OFFICER CHEMIST
Quality Assurance Quality Assurance Quality Assurance
Sterile APIs OSDs, Parenteral Solid & Liquid
Dr.Reddy’s Labs Orals
Cipla Ltd.
expertise
services

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projects
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2017 2015 2014 2014
GIVAUDAN SYSTA CARE PFIZER(Hospira) PRIME BIO
Commissioning & QMS Remediation & Commissioning & Validation & Process
Qualification Compliance Qualification
expertize
services

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projects
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2011 2010 2009
ADCOCK INGRAM MERCK(BIOE) SYNGENE(BIOCON)
QMS Remediation & Commissioning, Commissioning,
Commissioning, Qualification & Validation Qualification & Validation
Qualification & Validation
  Systemic approach in Quality Remediation & Compliance
 Efficient & Effective Implementation of QMS and cGMP Practices
 Adapt Latest Commissioning & Qualification Approaches
consultancy

 Adept in overall Verification, Validation Management – Mech & Process

expertize
services
audits

75% 90% 72% 74%

Quality Remediation & Implementation of Commissioning & Validation

Compliance QMS & cGMP Qualification Management
  Effective Planning, Scheduling & Execution of activities
 Adapt High level documentation & Practices
consultancy

 Profound Technical knowledge in applying Mandatory Guidelines

expertize
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 Timely accomplishment of Targeted Deliverables

70% 77% 91% 84%

Planning & Execution Documentation & Technical Knowledge Deliverables

Practices
 Many companies are currently being faced series of quality compliance issues, various
data integrity issues, poor implementation of cGMP & QMS, Inconsistent practices,
Inadequate procedures, Inconsistent final drug product quality, No proper awareness on
C&Q requirements, lack of knowledge in identification & implementation of Training needs,
whose are critical to business success.

consultancy
services

To overcome the above critical challenges, and other non-compliances,483's,every

audits

about
Pharmaceutical/Biopharmaceutical/Life Sciences company mandatorily update their
SME

Standards by adapting current regulations and advancements in achieving business

objectives.
By hiring expert consultants, or SMEs will have greater & significant benefit and
been historically proved with many MNCs as well.
Key Drives/Benefits :
 Key Focus on grey areas for substantial improvement
 Strategic Ideology followed to align with Regulatory Standards
 Tailor made technical solution for every technical issue
 Elimination of barriers to acknowledge and implement faster
 Human
Vaccines

Pharma
services
audits

Biotech/Biologics

about
rates

SME
Validation
Management Quality
Management

Commissioning &
Qualification
 $110/hour (On need basis)
reference
services

history
$80/hour on contractual basis (minimum 6 months)
audits

about
rates
Notes:
The above indicated pay cost details are approximate and based on the agreed-upon work scope
and deliverables.
The said costs exclude accommodation, local transport and flights.
All other applicable taxes are extra (if any).
 01 02 03

NO PIC

reference
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JIGNESH DESAI Dr.Tara Jayaram Rajeeva Lochan
ABARIS BIOCON GROUP NNE
 QMS and CGMP Commissioning &
Remediation & Compliance Qualification
Implementation Project Overview Documentation
Quality Risk Assessment Planning & Execution

expertise
Overall cGMP/QMS/SOP Documentation MEP co-ordination

services

history
projects
Equipment and Document Certification
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about
Audits Validation
Gap Analysis Validation Life Cycle Documentation
Mock Audits Equipment Validation
Vendor/Supplier GMP Audit Area/Facility Validation
Regulatory Audit compliance Process/Cleaning Validation
Sterilization Validation

Training Corporate
Basic cGMP Policies, Procedures, Standards
Technical Document Harmonization
On-the job Organizational Quality Documentation
QMS,GDP Regulatory Audit Preparedness
Data Integrity
 MCC
WHO- MHRA MCA
USFDA

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Geneva

projects
TGA

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3 7 3 5
Aurobindo Dr.Reddys Cadila Dr.Reddys
Cadila Aurobindo Aurobindo Aurobindo
Adcock Indian Immunological Dr.Reddys Cadila
Biological E
Akums