Naresh Kumar.

I
Mobile: +971-528420182
Emails: nareshkumar.inti@gmail.com, naresh_biochem@yahoo.com
____________________________________________________________________________

SUMMARY:
Possess 10 years of experience in Bio Pharma & pharmaceutical industry specifically in
vaccine and sterile pharmaceutical injectable manufacturing.
Subject Matter Expert (SME) in Commissioning, Qualifications and Validations (CQV) and
Quality systems.
Successful Bio chemistry with vast experience in Quality Assurance, project management,
quality engineering and validations.
Independently managed CQV and Quality assurance teams for Biotechnology and
Pharmaceuticals projects.
Lead several projects successfully as a team leader, supervisor and manager implementing
creative, scientific based, and patient safety centered approaches to minimize validation time
and cost.
Worked under strict deadlines and fast paced environment.
Involved in Facility Design, Utilities & Equipment Design, Flow / Zoning / Equipment Layouts
and provided improvements
Authored numerous User Requirement Specifications (URS), Design Qualification (DQ),
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
and Re qualifications (RQ) documents.
Possess sound knowledge on Clean Utilities
Quick learner, self-motivating, proactive, team player, and proficient in Microsoft Office

ACADEMIC QUALIFICATIONS:
Master of Science in Biochemistry from Acharya Nagarjuna University in 2004.
Bacholar of Science in combination of Chemistry, Botany & Zoology from Acharya
Nagarjuna University in 2002.

Professional experience:
Gulf Pharmaceutical Industries (Julphar) - UAE

Feb 2013 Present

Gulf Pharmaceutical industries is the Largest Pharmaceutical and Bio Pharmaceuticals

Company in the Middle East. The company is Approved by FDA,EU and WHO. The company
also possesses the all Sterile Aseptic and Terminal sterilization (Ampoule, Vial and sterile
powder) and Non sterile all dosage forms (Tablets, Capsules, Syrup, Suspensions, drops,
Ointments and creams).
Assistant Manager, Qualification and Validation Group Leader:
Worked closely with external consultants, international clients (eg: SAGENT, Paraxel,
MERCK), vendors and engineering contractors (Remoin, Bausch+stroebel, CAM and
Fedegari) and coordinating with other departments like Engineering, Regulatory, QC,
Process and Warehouse.
Member of SME group to resolve technical issues related to CQV with SAGENT, Paraxel and
any other vendor / consultant, as and when required.
Scheduled, planned and managed validation projects for Sterile and Non sterile Pharma and
Bio Pharma facility and supervised execution activities. Other responsibilities include
overseeing Factory Acceptance Tests, execution of Site Acceptance Tests, and performing
vendor audits.
Continuously monitored the progress of project to meet the scheduled timelines and provided
updates to the senior management.
Review of Validation master plans (VMP) and Site Master files.
Reviewed variety of validation documents such as URS, Functional Requirement/Design
Specifications (FDS), Validation Plans, DQ/IQ/OQ/PQ protocols and summary reports
associated with Process Equipment (LAFUs, Vessels, Fermentor, Autoclaves, Vial, Ampoule
washing machines and Filling Machines, SIP Systems, CIP Systems), Utilities, HVAC etc.
Reviewed layouts for Differential Pressure, Air Classification, Men Flow,Material Flow, Drain
layout, Equipment layout etc.
Generated and / or reviewed IQ/OQ/PQ documents for Clean Utilities such as Purified Water,
Water for Injection (WFI), Pure Steam Generation & Distribution Systems.
Prepared and / or reviewed SOPs for Validation department
Handled Change Controls and performed assessments on the proposed changes for
compliance with internal requirements and external (agencys) regulations.
Provided recommendations and suggestions during CAPA review to avoid recurrence as a
Member of the Julphar Corporate Compliance Group for deviation investigation.
Handled shutdowns by preparing shutdown plans with list of action items for post closure of
shutdown.
Reviewed Preventive Maintenance schedules and activities
Performed internal audits of cross-functional departments.
[

Executed closing of audit remediation points related to Validation Department.

Review of Ampoule, Vial and sterile powder Media fills.

 Review of Sterile and Non sterile Cleaning Validations.

Review of Sterile and Non sterile Process Validations.
Review of Freeze dryer and Terminal Sterilization Qualifications.

Biological E Ltd, Hyderabad - INDIA

Aug 2007 Feb 2013

BE is a pioneer in vaccine production and serving INDIA with more than 55 years. BEs
Shameerpet Unit is Asias biggest, export oriented unit with well made facility to suit USFDA
and WHO compliance. BEs is currently manufacturing DTP, TT, DT, Hep-B, DTPH, IPV, JEV
and Hib vaccines.
Assistant Manager, Corporate Validation Group:
Worked closely with external consultants, international clients (eg: Merck,GSK), vendors and
engineering contractors and coordinating with other departments like Engineering,
Regulatory, QC, Process and Warehouse.
Member of SME group to resolve technical issues related to CQV with Merck and any other
vendor / consultant, as and when required.
Scheduled, planned and managed validation projects for Biotech facility and supervised
execution activities. Other responsibilities include overseeing Factory Acceptance Tests,
execution of Site Acceptance Tests, and performing vendor audits.
Continuously monitored the progress of project to meet the scheduled timelines and provided
updates to the senior management.
Preparation and Review of Validation Master Plans.
Reviewed variety of validation documents such as URS, Functional Requirement/Design
Specifications (FDS), Validation Plans, DQ/IQ/OQ/PQ protocols and summary reports
associated with Process Equipment (LAFUs, Vessels, Fermentor, Autoclaves, Vial, Ampoule
washing machines and Filling Machines, SIP Systems, CIP Systems), Utilities, HVAC etc.
Reviewed layouts for Differential Pressure, Air Classification, Men Flow,Material Flow, Drain
layout, Equipment layout etc.
Generated and / or reviewed IQ/OQ/PQ documents for Clean Utilities such as Purified Water,
Water for Injection (WFI), Pure Steam Generation & Distribution Systems.
Prepared and / or reviewed SOPs for Validation department
Handled Change Controls and performed assessments on the proposed changes for
compliance with internal requirements and external (agencys) regulations.
Provided recommendations and suggestions during CAPA.
Handled shutdowns by preparing shutdown plans with list of action items for post closure of
shutdown.
Reviewed Preventive Maintenance schedules and activities
Performed internal audits of cross-functional departments.
Executed closing of audit remediation points related to Validation Department.

Indian Immunological Limited, Hyderabad -INDIA

June 2004 Aug 2007

Indian Immunological Limited is the third largest vaccine supplier in the Indian. It operates
one of the largest plants in the world for vaccines which is WHO-GMP and ISO-9001
certified.
Officer, Validation Group:
Prepared IQ, OQ, PQ documents for all equipment.
Performed validation of Heating, Ventilation and Air Conditioning systems associated with
Clean Rooms that include particle counting (viable & non-viable), air changes calculation,
airflow pattern monitoring etc.
Executed validation of Water Systems (Phase I, Phase II, Phase III) including Demineralised
Water, Purified Water and Water for Injection
Executed media fill trials for Filling Lines.
Performed temperature mapping of Autoclaves, Cold Rooms, Deep Freezers, Incubators,
Ultra Freezers etc.
Executed validation of Fermenters, Blending Vessels & Process related vessels etc.
Review of all Water Systems output quality for compliance to in-house standards viz.
Conductivity, pH, Microbial Analysis, Endotoxins, Chemical Analysis.
Audited the production blocks for non-compliance (Internal Audits).
Provided technical support and trouble shooting for production equipment such as Autoclave,
Water systems, Laminar Air Flow Systems etc.
Commissioning of equipments, interacting with vendors for required documents
Achievements
One of the leading team member (SME) for who participated in activities by WHO Geneva
Prequalification of TT Vaccine in Biological E Ltd 2008 to 2009.
One of the leading team member (SME) for who participated in activities by WHO Geneva
Prequalification of Recon Penta Valent Vaccine & Liquid penta (DTwP-Hep B + Hib) Vaccine
in Biological E Ltd 2010 to 2012.
One of the leading team member (SME) for who participated in activities by WHO Geneva
prequalification of Japanese Encephalitis (JEV) vaccine in Biological E Ltd 2012.
Active participant in SAGENT, GSK, Merck, Pfizer, Saudi, Turkey, Invima customer audits.
Lead the validation group and successfully faced the SAGENT, PARAXEL, MSD and Dance
Pharma (USA) customer audits - 2013 to 2014.
Actively participated in JFDA, EGYPT, SAUDI MOH, UAE MOH Audits 2013 to 2014.
One of the leading team member who participated in FDA consultant (BCG) Audit.

Personal Information
Name

: Naresh Kumar. I

Fathers Name

: Eswaraiah

Date of Birth

: 13/08/1982

Address for communication

: C/ Vinod Kumar, H.No 1- 208 D3, Thotavari street,

Markapur Post - 523316
Prakasam D.t, A.P.INDIA.

Nationality

: Indian

Marital Status

: Married

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