CV _Suresh Revanna_2016

CURRICULUM VITAE
OBJECTIVE
To excel in the field of Analytical development, Quality Assurance and Compliance to Regulatory
requirements of Pharmaceutical industry, well versed in 21 CFR compliance for Application software
CONTACT INFORMATION
Mr. SURESH S. REVANNA
Email: revannasuresh31@rediffmail.co
m
Mobile: 09160046222 / 7093704622
Current Location: HYDERABAD
Permanent Location: Bangalore
Present Address: Permanent Address
F. No. 12, BLOCK NO-6 #34,4th
main Road,
KENDRIYA VIHAR APTS AECS LAYOUT
NEAR MIYAPUR BUS BODY SANJAYNAGAR
MIYAPUR BANGALORE-560094
HYDERABAD - 500049
PERSONAL
INFORMATION
Date of birth: 29/12/1975
Marital status: Married
Languages Known: English.,Kannada, Hindi, Tamil, Telugu and Marathi
Nationality: India
Passport : K6412651 (Validity 25-Jun-2022)
PROFESSIONAL AND EDUCATIONAL
DETAILS
Professional Skills Have 16+ years’ experience of Pharmaceutical development with major
strength in Analytical development and Validation for pharmaceutical
dosage forms and, Documentation, Quality assurance and review of
Data for Compliance. Strong technical skills on CSV to meet 21 CFR
compliance
Current Employer Novartis Healthcare Pvt Ltd, Hyderabad, Telangana
Previous Employer Emcure Pharmaceuticals Ltd, Pune, Maharashtra
Brown & Burk Pharmaceuticals Ltd, (MICRO LABS) Hosur, Tamil Nadu
Sanford Analytical Labs. Bangalore, Karnataka
Professional Qualifications
B.Sc. in Chemisrty
M.Sc. in Environ. Chemistry
Diploma in I P R
From Mysore University, in July 1997.
From Mysore University, in July 1999.
Diploma in Intellectual Property Rights conducted by Symbiosis Law

College Pune India,. 2007
PROFESSIONAL EXPERIENCE:
 Since 04th October 2010 to till date, working with Novartis Healthcare Pvt Ltd. as
Principal Scientist in TRD-PHAD INHY Genome Valley Hyderabad.
 Worked with Emcure pharmaceuticals Ltd. Pune from 17 Jan 2005 to 22 Sept 2010
as Senior Research Fellow in (GMP & GLP) –in R&D Analytical Development &
Validn Cell.
 Worked with Brown & Burk Pharmaceuticals Ltd,Hosur, from 6th Mar 2003 to 31th
Dec 2004 in R&D-Analytical Development department as Executive in Method
development and validation Cell.
 Worked with Sanford Analytical Lab, Bangalore from 07th August 1999 to 29
February
2003 in Quality Control Analytical department as Analytical Chemist.
Current JOB RESPONSIBILITY at Novartis:
During my tenure of 5years at Novartis took different roles depending on the requirement and
build up needs. Following are the key deliverables.
 Key member for the site development since Novartis decided to build up in Hyderabad
 Took full ownership of site development during the initial years 2010 and 2011
 Management identified me as one of the key performer and gave the full responsibility of
setting up the site e.g lab infrastructure, compliance and Qualification in the year 2012.
Reporting to PHAD IN HEAD.
 Worked as team leader for Qualification and was responsible for the monthly progress
presentation in the year January 2012 to August 2013, directly reporting to PHAD
HEAD.
 In JUNE- 2013 to Dec-2014 moved. Projects to explore the project technical knowledge
where I was involved in the fast filing project LDK378 for which I was involved for
DS/DP validation and stability studies
 Performed the DS/DP validations and first time performed the FMEA studies from India
site and became the SPOC for all FMEA designs before the product went for Reg. stab
followed by filing
 Also worked for many other projects which were in different stages of the development
like Technical projects e.g PKC412, Clinical Project e.g. LGH447 and LCQ908, TAP311.
 Actively involved in the Reg-CMC Module documents authoring and reviewing the
technical part (analysis part) about 45 IMPD documents were reviewed and which was
highly appreciated by Reg CMC team and was completed by one month.
 During LGH447 Health authority queries were successfully answered and
recommended few additional studies as part of supporting the clinical development
phases of the project.
 For LCQ908 General medicine supported for all stability studies, Dissolution method
development on multimedia raw data review and preparation of DSR and RSRs
summary reports for regulatory filing .
 TAP311 clinical studies were supported for raw data review and update of DSR for all
the batches. And informing the progress to regulatory authorities.

 Updating the GLIMS specification depending on the stability studies and shelf life
extensions.
 Creation of Analytical methods and SSS update Development reports in TEDi database.
 Good knowledge on the GLIMS and was a super user for PHAD IN representing the site
at global level.
 Assisted review of Stability data packages for the team as anA3 reviewer, Also Worked
as Analytical Expert on few late phase Oncology projects assigned and the
contribution were recognized by Global in the category of Reach for LDK378. I was
involved in the validation of HGC capsules
 Designed FMEA during the validation and DoB to ensure the method is robust and can
be used during the stability
 Also supported many GLIMS protocol creation since I was also a super user the GLIMS
protocol creation was quick and was very supportive to initiate the stability studies.
 Supported the Regulatory team by reviewing the IMPD modules for the quick filing of
the product during the Zykadia submission.
 Also supported General medicines project during the development phase by
developing the dissolution method for the assigned projects
 Also supported the clinical phase during the stability studies and also writing the
stability reports for the regulatory purpose.
 In Jan-2015, Management decided for the key role to take up the team for Q&C
and identified me as the strong contender for my professional carrier growth
and hence moved to take the change where key objectives were as follows
 Lead the team of 12 associates for Q&C for the updates on key deliverables
 Key presenter in the monthly PHAD IN team meeting and update the Q&C
activities
 Resource allocation depending on the critical timeline request for all the team to
work closely to ensure the task completion
 Global represented for all Q&C activities and participate in the monthly QUEST
meeting.
 Overview of all the SLA agreements AMC & CMC contracts
 Decision making group for any new procurements of instrument based on the
project needs
 Meeting the QA expectation on the KQI and ensuring the quality parameter are
met
Good knowledge on the deviations , OOS/OOE and was deviation owner for 100+
cases raised during different project handling and qualification activities
My personnel skills and strong believer of Collaboration
 A dynamic and result oriented person. Work cool and clear on organizational needs.
 Work professionally and has a positive mind set.
 Very hard working, sincere and dedicated.
 Caters to demand when there is acute demand for review of qualification documents for
LU review.
 Has very good knowledge in equipment qualifications as per Novartis
processes/procedures.
 Has been a lead for the qualification team since its inception.
 Has been overseeing an increased number of instruments qualifications. During this

period was instrumental in bringing many improvements in the process and also solved
few troubles. Bought in many changes for the overall betterment of the qualification
process as well as compliance to the GMP requirements.
 Has always working towards team’s common goal and in the process & helps all his
team mates with required AE reviews when many other associates are not ready to take
up the activity. In the process has sometimes even overburden self but puts in extra
efforts and time to help team members complete their work in timelines. This shows the
ownership, commitment and sight on goals and timelines.
 Has also good at sharing the knowledge gained to his team members. For example he
constantly shares alert mails and information mails so keep associates aware of
requirements.
 Has a very good guide as owner and investigator and helped a lot in closing the cases in
time. Gives timely inputs and helps associates in avoiding mistakes. This shows his
supportiveness and good leader qualities. Has also very supportive in overseeing the
entire qualification activities. Thus he is a very supportive person both to his juniors and
seniors.
 Has also good at managing things. Has also instrumental in shaping up people for
different requirements like creating experts Category A, category B and Category C
instruments. This helped managing things at micro level and kept the process smooth.
 Is good at numbers and makes use of it in overseeing the numbers of ‘qualified’ and’ to
be qualified’ instruments numbers and also SOP’s.
 Supported HR as the Interviewer for the Hiring of fresh and experienced candidates for
the openings at Novartis Hyderabad.
Well versed with the Databases for Quality metrix
1) Trackwise AQWA for deviation, OOE/OOS
2) TeamAccess TQW for change control
3) LIMS (Labware) for Stability management, Reference standard and instrument
management
4) ESOPs for all Quality SOPs
5) TEDi for all DSR, RSR , Validation Protocols and specifications
6) I.Man tool for all incident management for IT support
7) DiARY database for all Qualifications and Software evaluations
8) LMS space for trainings related
9) SAP NetWeaver HR_CORE
10) Arrow for all C of A
11) KSO database for all MSDS management
12) TMS for talent management across the divisions
Strong Technical Skills
On 21 CFR compliance for Operating System (OS level) & Application Software’s used for
supporting the functional part of the Analytical instruments.
Qualifying the Application software in accordance to the guidelines and ensure the 21 part 11
CFR compliance and ERES verification
Supported as SPOC for all CSV for Novartis Hyderabad, and also represented India at a global
Forum

Nominated as Qualification Expert for India Site
Well versed in handling online tools like TrackWise, ESOPs, AQWA, GLIMS, GCDS, SAP and
CLM for monitoring critical quality attributes and training through LMS
AUDIT COMPLIANCE FROM VARIOUS REGULATORY AUTHORITIES
Involved and Successfully faced the audits form various regulatory authorities and received
the approvals form USFDA, MHRA, TGA, WHO. Poland HA , Canada HA,
Also Lead for all the compliance and GLP system related Audits faced from different
companies across India , about 25+ Audits faced.
ANALYTICAL INSTRUMENT EXPERTISE:
Working Experience in HPLC (Water, Dionex, Shimazu, Thermo) Gas chromatography
(Chemito, Perkin Elmer) U.V.-Vis Spectrophotometer (Shimadzu, Perkin Elmer) FTIR and
Dissolution apparatus (Vankel , Electrolab,Sotax) Karl Fischer (Metrohm Autotitrator)
Particle Size Analyzer, Bruker XRD, Particle Counter etc.
ACHIEVEMENTS:
Winner of the Best Performer of the year 2010 at Emcure Pharmaceuticals Ltd
Awarded as ABOVE & BEYOND for the contributions on setting up the site for Novartis.
2011
Team Award for the contributions on setting the Qualification strategy, 2012
Operational Excellence Award for successfully completing the 3 major Audits (Poland HA,
Canada HA & GCA) for site -2013
DCP (Deferred Cash Plan) Awardee for the year 2012 and 2014 for the best contributions in
the assigned Area.
Global TRD Awards in the category of Reach, for the best contributions on the project
LDK378 -2014.
Appreciation Award for the contribution in successful migration from XP to Win 7 without
impacting the business. 2015

CV _Suresh Revanna_2016

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