Covering Letter

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

Having over 22 years of experience in Commissioning, Qualification and Validation, Mechanical and Process
areas of reputed Pharma, Biotechnology, Vaccine Manufacturing, APIs and other GMP/Engineering
consultancy organizations in India and abroad.
Accomplishment of Ten successful major projects:
# Client/Project Name Location Support
01. Reliance Life Sciences, New Biotech Facility Navi Mumbai, India CQV
02. Syngene Biologics, New Facility Bangalore, India Overall CQV
03. Merck Vaccine Mfg. Project at BE Ltd New Facility Hyderabad, India Overall CQV
04. Adcock Ingram, New High Volume Liquid Orals Facility South Africa C&Q
05. Prime Biologics, Renovated Biotech Facility Singapore C&Q – Process Equipment
06. Pfizer Sterile Injectable Manufacturing New Facility Vizag, India C&Q – 2 suites
07. Givaudan Peshwa, New GMP F&F Mfg. facility Pune, India Overall C&Q
08. Syngene Project, New API Facility Mangalore, India Overall C&Q
09. Systacare Remedies, Renovated Sterile Injectable Facility Amritsar, India Qualification & QMS
10. Mega fine Chemicals, Facility Remediation Nashik, India Qualification, FDA Compliance
Also, significantly contributed in Validation Management Role for the following companies:
1. M/S Cadila Pharma Ltd;
2. M/S Indian Immunologicals Ltd;
3. M/S Aurobindo Pharma Ltd;
4. M/S Akums Drugs & Pharma Ltd,
5. M/S Dr. Reddy’s Laboratories Ltd; and
6. M/S Cipla Ltd.

Graduated in Pharmaceutical Science from Mangalore University and Post Graduated (MSQM) from Birla
Institute of Technology and Science, Pilani.
Professional Strengths:
 Adept in implementation of Latest Commissioning & Qualification Methodologies.
 Handled various equipment and systems pertaining to Solid Dosage Forms including pellets, dry
powders; Liquids; Parenterals; Vaccines; Plasma Proteins, and APIs.
 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 FAT & SAT.
 Generation of Commissioning Test Plans and 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,
- B. Pharma, MSQM
Technical Lead Engineer - CQV
242/3RT/1 l Masab Tank l Hyderabad - 500057 l India
M: +91-7032597309(WhatsApp) l +91-8008634796
Email: drameshglobal@gmail.com