Covering Letter

My skills and expertise would be ideally suitable for overall implementation of QMS & Remediation
activities, and undertaking of Commissioning, Qualification & Validation (CQV) assignments/projects of
New/existing Pharma/Life Science/Biotech.

Having over 20 years of experience in Quality Management, Commissioning, Qualification and

Validation, Mechanical and Process areas of reputed Pharma, Biotechnology, Vaccine manufacturing,
Sterile APIs and other GMP/Engineering consultancy organizations in India and abroad.

I had worked as Technical consultant for the projects successfully:

S.No Client/Project Name Location Support
Merck Biologicals Project(Kartik) at BE
01. Hyderabad,India Overall CQV)
Ltd New Facility
Adcock Ingram High Volume Liquid
02. South Africa C&Q,QMS Remediation
Orals Facility
03. Prime Biologics Singapore C&Q – Process Equipment
Hospira(Pfizer) Sterile Injectable
04. Vizag, India Overall CQV – 2 suites
Manufacturing New Facility
Systacare Remedies, Renovated
05. Amritsar, India QMS Remediation
Sterile Injectable Facility
Overall C&Q
06. Givaudan Peshwa, New facility Pune, India

Also, I had significantly contributed my skills and expertise by employing directly with reputed
companies including M/S Cadila Pharma Ltd; M/S Indian Immunologicals Ltd; M/S Aurobindo Pharma
Ltd; M/S Akums Drugs & Pharma Ltd, M/S Syngene International Ltd; M/S Reliance Life Sciences pvt
Ltd; M/S Dr.Reddy's Laboratories Ltd; and M/S Cipla Ltd handling various formulations.

Graduated in Pharmaceutical Science from Mangalore University and Post Graduated (MS in Quality
Management) from BITS, Pilani.

Roles Handled:
Quality Management System related:

 Systemic approach in Remediation and Compliance of Quality Management System

 Efficient Implementation of Quality Management System (QMS) Requirement
 Development of Quality Policies, Standards, Master plans, and Procedures
 Harmonization of Quality documents across divisional units
 Development of Standard Quality Assurance Procedures(QAPs)
 Conduct Quality Risk Assessment process(QRA)
 Effective Document Management System and controls
 Implementation of Sample Management process
 Carryout un-biased technical investigations (RCA)
 Gap analysis and conducting quality system audits
 Conduct Technical and awareness Training on guidelines
 Third Party vendor audits, compliance, and certification (cGMP)

CQV related:

 Adept in implementation of Latest Commissioning & Qualification Methodologies

 Development of Policies, Commissioning, Qualification and Validation Master Plans.
 Establishment of Validation Life Cycle Documentation as per ISPE, GAMP, ASME, ASTM etc.
 Identification and generation of User Requirement Specification(URS) and compliance
verification
 System and Component Level Impact Assessment (CLIA) and development of system
boundaries (SLIA) for criticality.
 Critical Review and compliance to Design Qualification(DQ), Factory Acceptance Test(FAT),
Site Acceptance Test(SAT), Turn Over Package(TOP) documentation
 Development of Quality Assurance Programme(QAP) and Inspection Test Plans(ITP)
 Witness, compliance, and certify the FAT & SAT documentation
 Generation of Traceability Test Matrices
  Write and execute Installation, Operational (IOQ), and Performance Qualification(PQ) protocols
and summary reports for equipment and systems
 Identify and drafting the Standard Operating procedures(SOP) and PM Schedules
 Development of Process Flow Charts and Master Batch Records and Conducting Process
Validation (PV) Studies
 Development of Sterile Assurance Validation protocols (Process Simulations) and their
execution
 Development of cleaning strategy/cycles and Carrying out Cleaning Validation (CV) Studies
(CIP/SIP).
 Timely accomplishment of Targeted Deliverables.

CV is as attached and revert for any additional information

Thanking you in anticipation.

Kind Regards,

D.Ramesh Babu
Technical Consultant
Validation & Quality Management
242/3RT l Masab Tank l Hyderabad - 500057 l India
M: +91-7032597309(WhatsApp) l +91-8247899827
Email: drameshglobal@gmail.com
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