D .

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

CAREER SUMMARY M: +91-7032597309/8247899827

CAREER OBJECTIVE:
Seeking for a challenging and demanding assignment in CQV function 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 20 years in CQV functions of pharmaceutical projects in
India, South Africa and Singapore 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 Commissioning, Qualification and Validation activities and having “hands-
on” experience in reputed Pharmaceutical and Biotech industries.

CORE SKILLS:
➢ Familiar with the latest regulations, guidelines and trends.
➢ All types of Pharmaceutical Validations including process; cleaning and sterile assurance.
➢ Critical equipment and systems qualification in Pharma and Biopharma.

SIGNIFICANT ACCOMPLISHMENTS:
❖ Successfully accomplished various Pharma and Bio-Pharma C&Q project assignments.
❖ Process and Cleaning validation successfully completed for various formulation range.
❖ Effective review, approval and implementation of documents including SOPs, Qualification, validation
and study protocols & reports in compliance with cGMP norms and global standards.

P RO F ES S IO NA L EX P E R IE NC E
My C&Q management experience includes the following projects:

▪ Givaudan (Peshwa), Pune, India

 ▪ Hospira Biotech (Pfizer), Vizag, India
 ▪ Syngene (Biocon), Bangalore, India
 ▪ Semler / Adcock Ingram, South Africa
 ▪ Biological E. Ltd (Merck), Hyderabad, India
▪ Reliance Life Sciences, Mumbai, India

Also, I too have hands-on CQV experience on several projects including:

 o Prime Biologics, Singapore
o Cadila Pharma, Ahmadabad, India
o Akums Drugs & Pharmaceuticals, Haridwar, India
o Indian Immunologicals, Hyderabad, India
o Aurobindo Pharma, Hyderabad, India
 


CAREER SUMMARY

TITLE: CQV MANAGER /ENGINEER NAME: D. RAMESH BABU

2017 - 2018 Project / Employer: Various pharmaceutical clients in India

Position: CQV Manager / Consultancy

Completion of Validation Management / Consultancy for two confidential

pharmaceutical clients in India, including the generation of high level validation
project documents, and the management of protocol generation, execution and
the close out of related reports.

2014 - 2017 Project / Employer: Process Engineering Specialists,

Singapore and India
Position: C&Q Manager

Responsible for the completion of consultancy work on various projects in India

and Singapore, and the management of teams of C&Q engineers on site.
Worked on several projects including:
• C&Q Lead for the Prime Biologics facility in Singapore
• C&Q Lead on a Sterile Injectable project for Hospira (Pfizer) in Vizag,
India.
• C&Q Lead for Givaudan New Green-field project in Pune, India

2013 - 2014 Employer: Cadila Pharmaceuticals, Ahmadabad, India

Position: Sr. Validation Manager

Responsible for generating high level validation documents, and the

management of protocol review, execution and the close out of related reports.

2013 -2013 Employer: Akums Drugs and Pharmaceuticals, Haridwar, India

Position: Sr. Validation Manager

Overall Validation Management and mentoring Team for performing in

generating and executing Qualification and Validation protocols.

2012 - 2013 Employer: Indian Immunologicals Ltd., Hyderabad, India

Position: Validation Manager

Activity Planning, review, approve and execute CQV protocols and their
reports.

2011 - 2012 Employer: Aurobindo Pharma Ltd., Hyderabad, India

Position: Corporate Validation Manager - Formulations

Development and Harmonization of corporate policies, procedures, templates,

Life cycle documentation, protocols, reports and implementation of validation
software’s.
 

CAREER SUMMARY

TITLE: CQV MANAGER/ENGINEER NAME: D. RAMESH BABU

2010 - 2011 Project / Employer: Semler (Adcock Ingram), South Africa

Sr. Manager – C&Q

Responsible for the completion of Commissioning and Qualification of.

Equipment/ Systems in New facility. Re-validations for the existing facility
equipment and systems.

2009 – 2010 Project / Employer: Biological E. Ltd., (Merck), Hyderabad, India

Position: Manager - CQV

Responsible for the completion of Commissioning and Qualification

of. Equipment/ Systems in New facility.

2008 - 2009 Project / Employer: Syngene (Biocon), Bangalore, India.

Position: Dy. Manager - CQV

Managed all aspects of validation on site, including managing a team of

validation engineers and follow-ups with equipment vendors.

2006 - 2008 Project / Employer: Reliance Life Sciences, Navi Mumbai, India
Position: Sr. Executive – Validation

Responsible for establishing and streamlining Corporate Quality

Management Systems (QMS) and Validation software’s across all
Formulation divisions.

2004 - 2006 Employer: Aurobindo Pharma Ltd, Hyderabad, India

Position: Executive - Validation

Responsible for accomplishment of process equipment and utility

systems qualifications including HVAC for Sterile API (Cephalosporins)
facility.

1998 - 2004 Employer: Dr. Roddy’s Laboratories Ltd., Hyderabad, India

Position: Officer – Quality Assurance(Validation)

Mainly involved in conducting Process Validation, Cleaning Validation and

Sterility Assurance Validations.

1997 - 1998 Employer: Cipla Ltd., Mumbai, India

Position: Chemist – Quality Assurance

Handled IPQA related activities and Monitoring Quality compliance.

 

CAREER SUMMARY

TITLE: CQV MANAGER /ENGINEER NAME: D. RAMESH BABU

S T R E NG T H S

✓ Flexibility and Openness to influence.

✓ Good concept developer, critic and Team Player.
✓ 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.

E D UCA T IO NA L Q UA LI F I CA T IO NS

MS in QUALITY MANAGEMNT 2009-2011

BITS, Pilani, Jaipur, Rajasthan.

Bachelor Degree in PHARMACY 1992-1996

N.G.S.M College of Pharmacy, Mangalore University,

P ERS O NA L IN F O R MA T IO N

Name : Mr. D. Ramesh Babu

Father’s Name : D. Venkateswara Rao

Date of Birth : 15th May 1974
Marital Status : Married
Languages Known : English, Hindi, Telugu &Kannada
Nationality & Religion : Indian & Hindu
Passport Number : G6255884

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