D.

RAMESH BABU
MIG 366, Surya City
Chandapura, Bangalore
dramesglobal@hotmail.com
drameshglobal@gmail.com
Ph: +27715202679 (South Africa)
+91-9676105039(India)

CURRICULUM VITAE
CAREER OBJECTIVE:
Seeking for a challenging and demanding assignment in Quality Assurance/Validation
function at senior level in a professionally managed organization, where I can utilize my
core competence and inherent techno-commercial skills for the organizational success.
BACKGROUND:
Impressive and result oriented career spanning over 13 years in Quality Assurance/
Validation functions with distinction of steering improvement initiatives with focus on
streamlining & managing operations with proactive planning, introducing new concepts, steering
change etc. for top-notch companies with consistent contribution to increased performance.
PROFESSIONAL EXPOSURE:
Having an excellent exposure in Quality Assurance and Validation departmental activities
and having “:hands-on” experience in reputed Pharmaceutical and Biotech industries i.e.
Cipla Ltd (Various solid dosage forms), M/S Dr.Reddy’s Laboratories (Injectables, Liquids
and various solid Dosages), M/S Aurobindo Pharma Ltd (APIs), M/S Reliance Life Sciences
(Bio-Pharmaceuticals & Blood Plasma Products),M/S Syngene International Ltd (Biocon
Group)-Biopharmaceuticals and M/S Semler Research Center (Currently working as project
lead at M/S Adcock Ingram, South Africa).
CORE SKILLS:
 Familiar with the latest regulations, guidelines and trends.
 All Pharmaceutical Validations.
 Critical equipment and system qualifications in Pharma and Biopharma
 Participated Regulatory and Customer Audits.
 Effective Implementation and continuous monitoring of Quality Management
System.
SIGNIFICANT ACCOMPLISHMENTS:
 Involvement in Regulatory Audits like USFDA, MCC, WHO and other quality audits.
 Participated in successful completion of Qualification and Validation phase for new
Bio-Pharma project (Fully Automated) at M/S Reliance and Syngene Intl Ltd.
 Process and Cleaning validation successfully completed for various products
 Effective and timely review, approval and implementation of documents including
SOPs, Batch records, specifications, Qualification, validation and protocols &
reports and stability protocols in compliance with cGMP norms and global standards.
 Implemented effective failure investigation procedures for various system, process
and product failures.
P R O F E S S I O N A L E X P E R I E N C E
KEY JOB RESPONSIBILITIES
o Ensuring the effective implementation of the best Quality Management Systems
in the Organization.
o Preparing Quality Policy and Quality Plans
o Acting as interface for statutory agencies
o Quality / System Implementation:
o Undertaking Programme finalization and co-ordination
 o Training of all employees as per schedules

o Monitoring progress vis-à-vis target dates

o Carrying out the required certification procedures
o On-going monitoring and suggesting remedial measures
o Quality Training Activities:
o Generating / maintaining quality thrust across all departments and
amongst all employees through training programmes
o Following up of improvement measures highlighted during training
programmes.
o Introducing latest approaches, advances and thinking in the field
o Supplier Quality Assurance:
o Assessment / approval / training / rating to assist the purchase
department
o Inspection at supplier end
o Shifting focus to instill ‘inbuilt quality’ concept in the supplier
o Monitoring of Quality System:
o Annual Product Quality Review
o Deviation Control system
o Change Control system
o OOS and OOT tracking system
o Customer Complaints Investigation system
o Training system
o Specifications and Test methods complete up-dating
o Stability study system
o Reserve sample storage and tracking
o SOP Control system
o Pest Control Programme
o Qualifications and Validations
o Calibrations
o IPQA activities
o Pre-dispatch audit system
o BMR / BPR control
o Self Inspection Programme / Internal Audit
o Functional:
o Manpower deployment in Quality Assurance Department
o Planning for training gaps identification and training calendar
o Planning for relevant Quality Assurance systems & procedures
o Submitting un-biased investigation summary with complete root cause
analysis in problematic areas of manufacturing operations
M/S Semler, Bangalore (Deputed to work at Adcock Ingram Ltd in South Africa) as
Senior Manager-GMP/Validation (Jun’10 to till Dt)
Equipment, Utility Systems, Facility, Process, Cleaning, QMS for various dosage forms:
 Preparation of documents such as Master Plans, Project Plans, System and Process
specific Plans.
 Conducting GAP Analysis and Risk Assessment.
 Conducting Design Review for the New Pharma/Biopharma Projects.
 Test Protocols and their Report Development for Commissioning, Qualification,
Validation and Other Studies.
 Monitoring and Review of Equipment, Area, Facility and system Re-qualifications.
 Review and Approval of Automated Systems Documentation.
 Guiding, directing, planning and responding to reporting sub-ordinates.
 Review and Approval of all departmental SOPs, Batch Records, Protocols, Reports,
Product Specifications.
 Monitoring and ensuring compliance of various quality measures & cGMP norms
during manufacturing and also co-ordination in preparation, checking, maintaining
and updating documents as per cGMP norms and other Regulatory Requirements.
  Revamping workflow processes for integration of quality systems and effective
implementation of Quality Management systems to ensure the sufficiency and
effectiveness of GMP related training, to support the business growth and prevent
quality and regulatory risks.

 Organizing monthly Reviews, Quality issues with the concerned Depts, and
drawing the action plan and compliance checking.
 Participating in Regulatory/Customer Audits and co-coordinating with the all the
concerned depts. for response compliance as part remediation.
 Conducting Internal Audits as per Regulatory Requirements and interaction with
all concerned depts. for compliance.
 Supporting in Compilation, review, responding and strategizing Regulatory
submissions.
M/S Syngene International Ltd ( Biocon Group) as Dy.Manager – Quality Assurance
(Jun’08 to Jun’10).
Handled QA, Validation Activities of Biologics Division:
 Preparation of Validation Policy documents, Commissioning, Qualification and
Validation Master Plans.
 Protocol and Report Development for Installation Qualification, Operational
qualification, Performance Qualification, Sanitization/Sterilization Validation,
Process Validation, Cleaning Validation, Aseptic Media Fill Validation.
 Protocol execution for Installation, Operational Qualification, Performance
Qualification and Sterilization Validation for equipment and systems.
 Equipment, Area, Facility and system Re-qualifications.
 Conducting Aseptic Media fill validation studies for SVPs, LVPs and PFS.
 FAT and SAT document certification prior to qualification.
 Review and Approval of Building Management System (BMS), Automated Solvent
Dispensing System (ASDS), Supervisory Control and Data Acquisition System
(SCADA), Heating Ventilation and Air Conditioning System (HVAC), Distributed
Control system (DCS), Functional Design Specifications (FDS) and Analytical
Cleaning Method validation (AMV) protocols.
 Monitoring and ensuring compliance of various quality measures & cGMP norms
during manufacturing and also co-ordination in preparation, checking, maintaining
and updating documents as per cGMP norms and other Regulatory Requirements.
 Revamping workflow processes for integration of quality systems and effective
implementation of Quality Management systems to ensure the sufficiency and
effectiveness of GMP related training, to support the business growth and prevent
quality and regulatory risks.
 Conducting Vendor Audits for Raw and Packaging Materials (Domestic Suppliers).
 Organizing monthly Reviews, Quality issues with the concerned Depts, and
drawing the action plan and compliance checking.
 Certification of Testing Equipment, Instrument Calibration and Preventive
maintenance Schedules.
M/S Reliance Life Sciences as Sr. Executive – Validation (Jun’06 to Jun’08)
Handled QA, Validation Activities of Biopharmaceuticals Division:
 Transfer of Technology to commercial scale batches and Scale up studies.
 Process validation studies for Pilot scale batches/Regular batches.
 Preparation of Policy documents such as Site Validation Master Plan,
Commissioning and Qualification Master Plan and Computer System Validation Plan
(CSVP).
 Protocol Development for Commissioning Test Plan, Installation Qualification,
Operational qualification, Performance Qualification, Sanitization/Sterilization
Validation, Process Validation, Cleaning Validation, Aseptic Media Fill Validation.
 System and Component Level impact assessment and development of system
boundaries for criticality.
 Preparation of Reports for Qualification, Process Validation, Cleaning Validation
and Equivalence Study.
 Installation, Operational Qualification, Performance Qualification and Sterilization
Validation protocol execution for all equipment and systems.
  Equipment, Area, Facility and system Re-qualifications.
 Effective handling and usage knowledge of Validation instruments such as Aerosol
photometer, particle counter, Data logger, Anemometer, Temprecorder etc.
 Conducting Aseptic Media fill validation studies for SVPs, LVPs and PFS.

 Preparation of Cleaning Validation Master Plan and Execution of cleaning validation

 Execution of Cold chain qualification study for various products.
 FAT and SAT document certification prior to qualification.
 Review and Approval of Building Management System (BMS), Automated Solvent
Dispensing System (ASDS), Supervisory Control and Data Acquisition System
(SCADA), Heating Ventilation and Air Conditioning System (HVAC), Distributed
Control system (DCS), Functional Design Specifications (FDS) and Analytical
Cleaning Method validation (AMV) protocols.
M/S Aurobindo Pharma Ltd as Executive – Quality Assurance (Apr’04 to Jun’06)
Handled QA, Validation Activities of Sterile API’s Division:
 Transfer of Technology to commercial scale batches and Scale up studies.
 Conducting Process validation studies for Pilot scale batches/Regular batches.
 Protocol Development and Review of Installation Qualification, Operational
qualification, Performance Qualification, Process Validation, Cleaning Validation
and Comparability/Equivalence study (CMC).
 Preparation and Review of Reports for Qualification, Process Validation, Cleaning
Validation and Equivalence Study.
 Installation, Operational Qualification and Performance Qualification protocol
execution for all equipment and systems.
 Conducting Equipment, Area, Facility and system Re-qualifications.
 Preparation of Cleaning Validation Master Plan and Execution of cleaning validation
 Review and Approval of Building Management System (BMS), Automated Solvent
Dispensing System (ASDS), Supervisory Control and Data Acquisition System
(SCADA), Heating Ventilation and Air Conditioning System (HVAC) and Analytical
Cleaning Method validation (AMV) protocols.
 Monitoring and ensuring compliance of various quality measures & cGMP norms
during manufacturing and also co-ordination in preparation, checking, maintaining
and updating documents as per cGMP norms and other Regulatory Requirements.
M/S Dr.Reddy’s Laboratories Ltd as Officer – Quality Assurance (Sep’99 to Apr’04)
Handled IPQA Activities of Oral Solid & Liquid Dosage Forms and Parenterals Units:
 Review of all departmental Standard Procedures, Batch Records, Protocols,
Reports, and Product Specifications.
 Monitoring and ensuring compliance of various quality measures & cGMP norms
during manufacturing and also co-ordination in preparation, checking, maintaining
and updating documents as per cGMP norms and other Regulatory Requirements.
 Identifying Contract Manufacturing Locations and Compliance before start up of
Production and Preparation of GMP Contracts.
 Supporting in Compilation, review, responding and strategizing Regulatory
submissions.
 Monitoring of Raw, In-Process, Bulk, Finished Product & Swab and Rinse samples.
 Monitoring Control sample Collection, Storage, review, retrieval and destruction.
 Domestic and Export Batch Execution, Certification and Release for Finished
Pharmaceuticals.
M/S Cipla Ltd as Chemist – Quality Assurance (Feb’97 to Sep’99)
Handled QA Activities of Oral Solid Dosage Forms Unit:
 Line Clearance before starting of new batch / product.
 Stratified sampling during pre-validation and validation batches.
 Monitoring of online documentation & cGMP compliances in manufacturing areas.
 Handling of Deviations and incidents.
 Handling of customer complaints.
 Domestic and Export Batch release and Certification.
 Training to production personnel on SOPs and changes. Train the operators, officers and
executives on production SOPs and CFR, ICH guide lines.
 Internal auditing. Audit the production, warehouse, Engineering and QC facilities and
coordinate to fill up the gaps as per guidelines (c-GMP).

A R E A S O F E X P O S U R E
 Tablets, Capsules, Pellets, SV/LV Parenterals, Liquids, APIs and Biopharmaceuticals.
 Regulatory Audits of Indian FDA, MCC, WHO, MCA & US-FDA.
 Gap Analysis and Risk Assessment
 Different validation Techniques.
 New Project related FAT & SAT Documentation.
 Cleaning Validation including CIP and SIP.
 Effective Handling of all Pharma Validation Test Equipment.
 Exposure on globally accepted validation document preparation under the guidance
of the leading US based consultancy (M/S Alfalaval).

A C T I V E P A R T I C I P A T I O N
 Resolving Trouble shooting by forming the cross-functional Team (CFT) for quality
improvement.
 Participated in Tier Two Audits.
 Tackling of Market complaints.
 Representative for Loan License Party.
 Effective handling of manpower in Team environment and also ability to work
independently.
 Participation in Quality audits and Customer Audits and follow-up for the corrective
action.
 Qualifications, Validation including Process and cleaning.
 Good Understanding with Eng Guidelines like GAMP, ISPE, ASME BPE.
 Familiar with ISO 9000 and 14000 series, ICH series, EU-GMP, Schedule-M,GLP and
others.
T R A I N I N I N G P R O F I L E
 SAP & ERP applications and online working (at DRL & APL).
 ISO 9000-2001 Training at Aurobindo Pharma Ltd.
 OECD Principles on GLP at SIL.
 21 CFR Part 11 Training
A C H I E V E M E N T S
Major changes suggested and Implemented number of cost reduction procedures
without compromising the quality.
System implications as required for MCC, MCA, TGA, WHO and USFDA
Requirements.
Number of Appreciation Memos received from hierarchy for the useful contribution.
Implemented conceptualized system designated procedures.
High Level Qualifications and Validation Documentation meeting with the Global
Standards.
Executed prospective Process validation for new molecules of API, cleaning
validation for different products/facilities.
Reduced risk of failures by implication of QMS.
Sound documentation practices implemented in QA, Production and Validation.
S T R O N G P O I N T S
 Flexibility and Openness to influence.
 Good concept developer, critic and Team Player.
 Unquestionable integrity and ethical behavior.
 Precise, logic and well organized; goal oriented; constructive thinking and pro-
active; trustworthy.
 Good communication skills & collaboration with other teams; able to integrate the
other teams’ expertise and expectations for problem solving.
  Strong personality, ability to coach & motivate people; delegate tasks.
 Ability to adapt quickly to an evolving work environment; open-minded, willing to
learn from others.
 Ability to understand and train others in quality processes and standards.

A U D I T S F A C E D
o World Health Organization (WHO) at M/S DRL.
o Medicines Control Council (MCC-SA) at M/S DRL.
o Schedule-M Audits at M/S DRL, APL & RLS.
o US-FDA renewal audit at M/S APL.
o Danish Denmark at M/S DRL.
o GSK Audit at M/S APL.
o Korean FDA at M/S APL.
o NABL Audit at RLS.
o Major clients Pfizer, Merck, BMS Audits at Syngene
o GLP Pre-Inspection at Syngene
o Divisional Audits from Major clients
S U M M A R Y O F E D U C A T I O N A L Q U A L I F I C A T I O N S
MS in QUALITY MANAGEMNT (Pursuing) June 2009
Indian Institute of Quality Management (IIQM),
Jaipur, Rajasthan.
B.PHARMACY 1992-1996
N.G.S.M College of Pharmacy
Mangalore University, Mangalore (DK).
Intermediate from Board of Intermediate 1989-1991
V.S.R & N.V.R College,Tenali.
Secondary School Certificate (S.S.C) 1988-1989
S.R.R College.Tenali.
P E R S O N A L I N F O R M A T I O N

Name : D.Ramesh Babu

Father’s Name : Venkateswara Rao
Date of Birth : 15 th May 1974
Sex : Male
Marital Status : Unmarried
Languages Known : English, Hindi, and Telugu &
Kannada
Nationality : Indian
Passport Number : G625584
Religion : Hindu
Present Address : MIG-366, Surya City,
Chandapura,
Bangalore, Karnataka
India, Pin: 500100
Plot No: 2179, Meridian Plaza
Bedford view,
Johannesburg, South Africa

Permanent Address : 1-16-9, Gandhi Nagar

Tenali, Guntur, AP-522301

D.RAMESH BABU
Reference: Mr. Balachandra Nadig, General Manager-QA, GSK
Dr. Tara Jayaram, HOD –QA & Regulatory-Syngene International Ltd