Covering Letter

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

Having over 20 years of experience in 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.

Successful accomplishment for the following projects in contract role :

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
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 QMS Remediation &
05. Amritsar, India
Sterile Injectable Facility Validation Support
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.

Key Strengths:

 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.
Thanking you in anticipation.

Kind Regards,
D.Ramesh Babu
Freelancer – CQV Engineer/Manager
Validation & Quality Management
242/3RT/1 l Masab Tank l Hyderabad - 500057 l India
M: +91-7032597309(WhatsApp) l +91-8008634796
Email: drameshglobal@gmail.com