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QUALITY & VALIDATION MANAGEMENT PROFESSIONAL
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D.Ramesh Babu B.Pharm,MSQM
Independent Pharma Consultant
Commissioning, Qualification, Validation
Quality Management System
drameshglobal@gmail.com
+91-7032597309/8247899827
2017 2014 2013
1 2 3
background
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
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expertise
services
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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
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expertise
services
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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expertize
services
projects
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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.
1 2 3 4
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expertise
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2017 2015 2014 2014
GIVAUDAN SYSTA CARE PFIZER(Hospira) PRIME BIO
Commissioning & QMS Remediation & Commissioning & Validation & Process
Qualification Compliance Qualification
5 6 7
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expertize
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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
Consultant Role
expertize
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expertize
services
audits
consultant role
industries
services
about
Pharmaceutical/Biopharmaceutical/Life Sciences company mandatorily update their
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 proven with many Indian and 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
industries
services
audits
Biotech/Biologics
about
rate
Validation
Management Quality
Management
Commissioning &
Qualification
$100/hour (On need basis)
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rate
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
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NO PIC
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JIGNESH DESAI Dr.Tara Jayaram Rajeeva Lochan
Quality at ABARIS BIOCON GROUP Projects at NNE
Quality
QMS and CGMP Commissioning &
1 Remediation & Compliance
Implementation
4 Qualification
Project Overview Documentation
Quality Risk Assessment Planning & Execution
background
expertise
Overall cGMP/QMS/SOP Documentation MEP co-ordination
services
projects
Equipment and Document Certification
audits
about
Audits Validation
2 Gap Analysis
Mock Audits 5 Validation Life Cycle Documentation
Equipment Validation
Vendor/Supplier GMP Audit Area/Facility Validation
Regulatory Audit compliance Process/Cleaning Validation
Sterilization Validation
Training Corporate
3 Basic cGMP
Technical
6 Policies, Procedures, Standards
Document Harmonization
On-the job Organizational Quality Documentation
QMS,GDP Regulatory Audit Preparedness
Data Integrity
MCC
WHO-
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USFDA MHRA MCA
expertize
services
Geneva
projects
audits
TGA
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5 6 3 5
Aurobindo Dr.Reddys Cadila Dr.Reddys
Cadila Aurobindo Aurobindo Aurobindo
Adcock Indian Immunological Dr.Reddys Cadila
Biological E
Akums