D .

R AMESH B AB U
Plot No.:242/3RT, VN
Colony, Masab Tank,
Hyderabad-57, India.
drameshglobal@gmail.com
dramesglobal@hotmail.com
M: +91-7032597309

CURRICULUM VITAE E

CAREER OBJECTIVE:
Seeking for a challenging and demanding assignment in Quality Management/CQV function at senior level
in a professionally managed organization/project, where I can utilize my core competence and inherent
techno-commercial skills for the organizational success.

BACKGROUND:

Impressive and result oriented career spanning over 19 years in Quality Management/ CQV 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 Management System and Validation activities and having “hands-
on” experience in reputed Pharmaceutical and Biotech industries.

CORE SKILLS:
 Familiar with the latest regulations, guidelines and trends.
 Effective Implementation and continuous monitoring of Integrated Quality Management Systems
including Change controls, Deviations, CAPA, Failure Investigations, Non-conformances, Out of
Specifications.
 Risk Management Applications including FMEA, Akers-Agalloco methods.
 All types of Pharmaceutical Validations including process; cleaning and other sterile.
 Critical equipment and systems qualification in Pharma and Biopharma.
 Participated Regulatory and Customer Audits.

SIGNIFICANT ACCOMPLISHMENTS:
 Direct Involvement in Regulatory Audits like USFDA, MCC, WHO and other Quality Audits.
 Participated in successful completion of Commissioning thru Validation phase for Bio-Pharma project
(Fully Automated) at Reliance; Syngene; Adcock; BE; Givaudan.
 Process and Cleaning validation successfully completed for various formulation range.
 Effective and timely review, approval and implementation of documents including SOPs, Batch
records, specifications, Qualification, validation and study 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

 Quality System Implementation:
o Ensuring the effective implementation of Integrated Quality Management System in the
Organization.
o Establishing Quality Policies, Quality Plans, Master Plans, and procedures.
 Quality Training Activities:
o Training and monitoring of all employees as per schedules.
o Generating / maintaining quality thrust across all departments and amongst all
employees through training curriculums.
o Introducing latest approaches, advances and thinking in the field.
 Commissioning, Qualification, and Validation Activities:
o Covering all phases of Validation for all products, equipment, and processes.
o Protocol Development and their execution by adopting high level documentation
practices.
o Assessing project demands and Achieving the scheduled project timelines to ensure that
deliverables are executed in line with the project schedule.
 Functional:
o Experienced in leading teams and providing direction and motivation to other team
members.
o Submitting un-biased investigation summary with complete root cause analysis in
problematic areas of manufacturing operations and testing.
o Acting as interface for statutory agencies.

M/S Process Engineering Specialists (PES), Singapore as Lead Consultant (Dec’14 to Oct’17)
At Hospira Injectable C&Q Project, Vizag and Givaudan (Peshwa), Pune:
 C&Q Lead worked for the completion of consultancy work on various projects, and the
management of C&Q engineers on site.
 Planning and Project Management activities
 Development of Project Plan, Master Plan and scheduling the activities.
 Development of System/Component Level Assessment.
 Review and compliance to FAT, SAT, TOP documentation.
 Liaise with Cross Functional Departments for timely execution.
 Field Execution for P&ID walk down, weld, slope, physical attributes & functionality verification.
 Production Process Risk Assessment and action plan.
 Development of process and equipment protocol for formulation, labelling, filling, and packaging
for all products including all support systems and closeout related reports.
 Development of Study protocols; Cleaning Validation related to CIP/COP Development, Process
Validation protocols and their execution.
 Establishment of cycle times and process optimization for CPPs and CQAs.
 Development of Cleaning Validation protocols, cleaning assessments, and provide relevant
information for cleaning method development.
 Thermal Mapping Studies.
 Development of High level documentation related to Operation and Cleaning.
 Establishment of Quality Management systems and procedures.
At Prime Biologics Validation Project, Singapore:
 Development of Sterile Assurance Validation protocols and their execution for process
equipment.
 Technology Transfer with required Process set-up for scale-up production.
 Development of High level documentation related to Operation and Cleaning.
M/S Cadila Pharmaceuticals Ltd., Ahmadabad as Sr.Manager-Quality Assurance-Formulations
Division (Dec’13 to Aug’14)-USFDA, MHRA, TGA, WHO approved
Establishment and Monitoring of Quality Management System:
 Establish and implementation of Quality Management Systems and cGMP across the
organization and its units.
 Ensuring compliance with National and International standards and regulations.
 Risk Assessment as per the latest regulation across various aspects of pharmaceutical
manufacturing.
 Ensuring the compliance in the facility for regulatory audits and customer audits.
 High level documentation in compliance with the National and International Regulatory
requirements/guidelines.
 Unbiased Technical investigations, impact assessment of non-
conformances/deviations/failures/Market complaints and its management through effective
CAPA.
 Regulatory assessment of change control systems and evaluating quality impact.
 Implementation of all pharmaceutical qualifications/validations as per the current regulatory and
industry requirements.
 Review and approval all pharmaceutical documents such as technology transfer, technical
agreements, executed documents, QMS documents, stability study reports etc.
 Harmonization of procedures, practices related to QA/QC across the organizational units.
 Identify and evaluation of training needs for the functional teams of various levels to achieve
organizational success.
 Strategic and timely support for regulatory submissions for registrations.
 Vendor assessment and conducting Internal and external quality audits as part of the effective
continuous improvement.
 Co-ordinating with the cross-functional departments for trouble shooting for the effective
functioning.

M/S Akums Drugs and Pharmaceuticals Ltd., Hardwar as Sr.Manager-Quality Assurance-

Formulations Division (May’13 to Nov’13)-TGA, WHO approved
Establishment and Monitoring of Quality Management System:
 Provided leadership and QA oversight to ensure that drug substance manufacturing activities are
compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron
Standard Requirement Documents.
 Responsible for all aspects of QA Team including review and approval of the following types of
documents, relating to Master Documents, Protocols and Reports.
 Organized QA resource assigned to functional area to meet goals and timings; coordinates
prioritization of activities with area management.
 Performs compliance monitoring of area operations, including trending of failures and evaluating
effectiveness of corrective actions.
 Reviews customer requirements and implements required processes, as needed, to meet
customer expectations regarding Quality.
 Provides advice and direction to other company departments on quality issues.
 Participated in regulatory and customer audits.

M/S Indian Immunologicals Ltd., Hyderabad as Manager-Quality Assurance-Human Vaccines

Division (Nov’12 to Apr'13)-WHO Approved
Establishment and Monitoring of Quality Management System:
 Remediating and harmonization of all procedures and practices across the various business units
of the organization.
 Monitoring and ensuring the compliance of all IPQA and Validation activities.
  Ensuring compliance with National and International standards and regulations.
 Setting up and maintaining controls and documentation procedures.
 Identifying relevant Quality/Validation-related training needs and delivering training.
 Preparing clear explanatory documents in response to Audit observations, queries from state and
central regulatory authorities i.e. CDL, DCG(I),CDSCO etc.
 Monitoring the quality systems by gathering relevant data and producing statistical reports.
 Ensuring the continuous improvement in all aspects of Total Quality Management is developed
through a well-educated and adequately resourced workforce.

M/S Aurobindo Pharma Ltd, Hyderabad as Manager-Corporate Quality Assurance (Jul’11 to

Nov’12)-USFDA, MHRA, TGA, WHO, ANVISA approved
Establishment of Corporate Quality Management Systems across Formulation Units:
 Defining and Harmonization of procedures and practices across all Units.
 Overview the implementation of QMS software across all formulation units and ensure the
necessary documentation requirements.
 Global strategies are harmonized through collaborative relationships to ensure that appropriate
changes are identified and implemented.
 Promoting Quality achievement and performance improvement throughout the organization.
 Ensuring compliance with National and International standards and regulations.
 Agreeing standards and establishing clearly defined Quality methods for staff to apply.
 Setting up and maintaining controls and documentation procedures.
 Identifying relevant Quality-related training needs and delivering training.
 Preparing clear explanatory documents in response to Audit observations, queries etc.
 Monitoring the quality systems by gathering relevant data and producing statistical reports.
 Performs internal supplemental audits (Tier III) of a technical discipline to verify that facility
records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory
requirements.
 Checks the Gap analysis of quality and understands the reports of key quality indicators for
quality improvement.
 Continuous improvement in all aspects of Total Quality Management is developed through a
well-educated and adequately resourced workforce.

M/S Semler, Bangalore (Deputed to work at Adcock Ingram Ltd in South Africa) as Senior
Manager-GMP/Validation (Jun’10 to Mar’11)
Equipment, Utility Systems, Facility, Process, Cleaning and QMS for OSD & Liquid Orals Facility:
 Preparation of documents such as Master Plans, Project Plans, System and Process specific Plans.
 Conducting GAP Analysis and Risk Assessment.
 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 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.
 Participating in Regulatory/Customer Audits and co-ordinating 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 Biological E Ltd., Hyderabad as Manager-Quality/Validation (Mar’09 to Apr’10)
Equipment, Utility Systems, Facility, Process, Cleaning Vaccine production Facility:
 Supported Commissioning Engineering, Manufacturing Operations, Validation, and Quality
Assurance for eight months in a consultant role during plant start-up working with cell culture
manufacturing systems and equipment.
 Provided leadership, project management, and guidance to validation staff.
 Audited and Approved Project Engineering, Validation and Quality Assurance Turn Over Packages,
Commissioning Protocols, Qualification Documents and Validation activities for Reliance
Biosciences. Performed Part 11 Compliance assessment for Emerson Delta V control system.
Reviewed Functional Design Specification for accuracy prior to engineering approval.
 Audited and Approved Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents
as part of integrated Commissioning/Validation efforts for Media and Buffer Transfer Systems,
Glassware Washers, Autoclaves, and Large Scale Chromatography systems and Various Cell Culture
Bioreactors ranging from 10L to 2500L.
 Wrote and executed Installation, Operational (IOQ) protocols, for Chromatography Systems. This
includes media slurry, resin transfer and (Delta V) DCS control of the systems.
 Qualified automated transfer of media and buffer thru various transfer circuits.
Reviewed Delta V event and batch reports and worked with the team to bring the batch reports to
cGMP standards.

M/S Syngene International Ltd (Biocon Group) as Dy.Manager – Quality Assurance (Jun’08 to
Mar’09).
Handled QA, Validation Activities of Biologics Division (CMO):
 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:
 Process validation studies for Pilot scale batches/Regular batches of Plasma Fractionation Products.
 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.
 Conducted investigations on Preventative Maintenance and Calibration’s Programs for the Aseptic
Processing Area Equipment.
 Reviewed SOP’s, Validation, and schedules for PM’s and Calibration to meet due dates.
 Completed investigations and wrote final report for PM’s.

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’98 to Apr’04)-MCC

Approved
Handled IPQA Activities of Oral Solid & Liquid Dosage Forms and Parenteral 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 startup 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’98)

Handled QA Activities of Oral Solid Dosage Form 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, and Engineering and QC facilities and coordinate
to fill up the gaps as per guidelines (cGMP).

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, MHRA & US-FDA.
 Gap Analysis and Risk Assessment.
 Different validation Techniques.
 New Project related FAT, SAT, C&Q 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
consultants across the globe.
A C T I V E P A R T I C I P A T I O N

 Trouble shooting by forming the cross-functional Team (CFT) for quality improvement.
 Effective handling of manpower in Team environment and also ability to work independently.
 Participation in Quality audits and Customer Audits and follow-up for CAPA.
 Qualifications, Validation including Process and cleaning.
 Good Understanding with Engg 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

 ISO 9000-2001
 OECD Principles on GLP
 21 CFR Part 11
 Auditing Certification etc.

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, MHRA 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; maintain confidentiality, remain open to
others' ideas, 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);Medicines Control Council (MCC-SA); US-FDA audit; ANVISA
(Brazil); Iran, Kenya etc.
 o Schedule-M/CDSCO Inspections.
o Danish Denmark; Korean FDA; NABL Audit, GLP Inspection.
o ISO 9001:2008/ISO 14001.
o Divisional Audits from Major clients Pfizer, GSK, Merck, and BMS Audits.

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 2009-2011

BITS, Pilani, Jaipur, Rajasthan.

Bachelor in 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 : D. Venkateswara Rao
Date of Birth : 15th May 1977
Sex : Male
Marital Status : Married
Languages Known : English, Hindi, Telugu &Kannada
Nationality & Religion : Indian & Hindu
Passport Number : G625584
Permanent Address : Plot No.242/3RT, Vijay Nagar, Masab Tank,
Hyderabad-500057,India
Contact Numbers : +91-7032597309 (WhatsApp)
+91-8247899827
Contact Mail IDs : drameshglobal@gmail.com
dramesglobal@hotmail.com

D.RAMESH BABU

References: Dr.Tara Jayaram, Head –Quality & Regulatory – Syngene International Ltd.
Mr.Jignesh Desai, VP Quality & Regulatory – Abaris Healthcare Ltd.