G.Sravan Kumar is seeking a managerial role in quality assurance or quality control with over 8 years of experience in analytical functions, manufacturing, and packaging. He has experience handling regulatory filings, validations, audits, and stability testing. Currently working as an Assistant Manager at Syngene International Limited, he holds an M.Sc. in Biotechnology and B.Sc. in Chemistry, Biochemistry, and Microbiology.

1. G.Sravan Kumar
sravan.balu@gmail.com
91+ 7676776149
Seeking Managerial assignment in quality assurance or quality control department in
a progressive organization of repute that would enrich and enhance my skills where i
can contribute effectively to the organization.
• 8+ years of experience in Analytical function, In-process manufacturing and
packing and well versed with key responsibilities of Analytical department such as
Stability Chambers and Sample management, Analytical method validations,
Analytical method transfer(s) & stability testing, regulatory filings, exposure to
regulatory inspections and related documentation. Capable of handling
multitask in Quality Control, AR&D departments of Pharmaceutical Industry.
• Handling of regulatory/customer queries.
• Validation of AHU Systems, Walk-in Stability Chambers and Reach in Stability
Chambers.
• Drug License maintenance & Stability Protocol Preparation in LIMS.
• Well versed with cGMP, cGLP tools, and participated in audits by USFDA, MHRA,
TGA, etc.
• Having Rich experience in Empower, Labware LIMS software and Walk-in
humidity chambers software (ICDAS2.1).
• M.sc (Bio-Technology) from “Bangalore University”, Bangalore.
• B.sc (Chemistry, Bio-Chemistry, Micro-Biology) from “Sri Venkateswara
University”, Tirupathi.
• Currently working as “Assistant Manager” at SYNGENE INTERNATIONAL
LIMITED, in Bangalore from ‘Apr 2014 to till date. It’s a “BIOCON GROUP
OF COMPANY”.
PROFESSIONAL PROFILE
EDUCATIONAL QUALFICATION
CAREER PROFILE

2. • Worked as “Sr.Documentation Coordinator-Analytical Operations and
Support” at APOTEX RESEARCH PRIVATE LIMITED, in Bangalore since
Sep 2009 to Apr 2014.
• Worked as “Officer–Quality Assurance” at MEDREICH LIMITED, in
Bangalore since Jun 2008 to Aug 2009. (It’s a joint venture with ADCOCK
INGRAM Limited, South Africa.)
• Worked as a “Trainee-Quality Control” at BIOVEL LIFE SCIENCES, in
Bangalore since Dec 2006 to Jun 2008.
• Received outstanding performance award from Kiran Majumdar-Shaw at
Syngene International Limited.
• Received power up recognition award from Baxter at Syngene International
Limited.
• Received Certification of appreciation award from Baxter at Syngene
International Limited.
• Having Good communication skills and result oriented.
• Ability to take the initiative to work in and lead a team
• Perseverance and willingness to take initiative and self-motivation
• Aptitude to learn new ideas and quicker adaptation to the environment,
multidimensional view to resolve issues, willingness to learn, amicable team
member.
• Proficient in delivering timely and productive results in tight deadlines without
compromising quality.
MAJOR ACCOMPLISHMENTS ACROSS THE TENURE:
PERSONAL ATTRIBUTES

3. Designation : Assistant Manager
Department : Analytical and Stability Operations
Notice period : 3 Months
ANALYTICAL AND STABILITY OPERATIONS (Sterile IV Solutions and
Parenteral Nutrition)
Job Description:
• Leading Analytical and Stability Operations for commercial stability team for
Baxter USA and Europe.
• Global Stability Sample management.
• Handling Walk-in Humidity Chambers and Related Documents.
• Planning, executing and evaluating the validation data in parenteral nutrition and
renal products.
• Preparation and review of validation protocols, reports for various analytical
methods involving HPLC, GC, UV and Microbiological data
• Involved in qualification of large capacity Stability Chambers (i.e. 2.5 lakh
liters) with various conditions as per the client requirement.
• Preparation of standard operating procedures as per requirements.
• Responsible for updating the project status to the Baxter clients in USA and UK.
• Responsible for Stability sample analysis for US Commercial stability products
& R&D batches.
• Planning Stability program for the month.
• Monitoring of GLP/ GDP Practices in the Laboratory.
• Providing continuous improvement training to employees in the team.
• Conducting Laboratory Investigations, Preparation and review of Investigations,
Incidents, deviations, OOS and OOT reports and also responsible for implementation
of CAPA.
• Preparation, review and distribution of quality control documents and SOP’s.
• Responsible for Periodic calibration schedule and calibrating all analytical
instruments and equipments as per schedule.
CURRENT JOB PROFILE “A BIOCON COMPANY”(SYNGENE INTERNATIONAL
LIMITED):

4. PRODUCT EVALUATION AND ANALYTICAL SUPPORT (Tablets and Capsules)
• Global Stability samples Management.
• Preparation of Stability Study Protocol through Labware LIMS for Various
Stability studies like In use Study, Bulk Pail Study, Transportation Study etc.
• Provide analytical support & guidance to ensure completion of stability studies
as per the stability protocol.
• Calibrations carried out as per Master calibration schedule for critical instruments
and equipments.
• Stability Sample pullout through LIMS and Stability Chamber Management.
• SOP Preparation and stability data compilation.
• Review of Analytical data and LIMS generated documentation.
• Performed regulatory activities like Drug License Preparation for Drug Product
and API.
• Preparation and review of data submission sheets for ANDA, ANDS and INTL
Markets.
INPROCESS QUALITY ASSURANCE (Tablets and capsules):
• In-process Quality checks in Manufacturing, Packing and Analytical laboratory.
• Line clearance before batch commencement and product change over.
• To ensure that critical deviations and incidents are investigated and resolved.
• Coordinated with AHU Validation and Process Validation.
• Analytical data and Batch records review.
• To ensure that internal audits are performed at Laboratory and Manufacturing shop
floor and Packaging area.
• Handling of Change control, Market complaints, Deviations & Incidents. Approvals
and compilation of relevant data’s for justification.
• Preparation of documents such as SOP’s, Protocols, Validation Activities
• To conduct Training program.
• Handling of OOS and OOT in Co-ordination with respective departments
• Online reviewing of BMR and BPR’s and issuing of the Quality documents like
Sop’s.
PREVIOUS JOB EXPERIENCE: APOTEX RESEARCH PRIVATE LIMITED
PREVIOUS JOB EXPERIENCE: MEDREICH LIMITED (ADCOCK INGRAM):

5. • Calibration of laboratory instruments HPLC, GC, and Disso etc.
• Performed environmental monitoring in the laboratory.
• Performed LAL test and chemical analysis for WFI.
• Protein estimation in vaccine.
• AHU validation activity.
• Well exposure to various types of audits like USFDA, MHRA, MCC
(SOUTH AFRICA) AND TGA
• HPLC
• GC
• DISSOLUTION
• IR
• UV
• AUTOCLAVE
• LAMINAR AIR FLOW UNIT
• INCUBATOR
• FRIABILATOR
• Tablet hardness, thickness, weight variation testing instrument.
• WALK IN HUMIDITY CHAMBER AND PHOTOSTABILITY CHAMBER
• AHU
PREVIOUS JOB EXPERIENCE: BIOVEL LIFESCIENCES:
AUDITS:
KNOWLEDGE ON INSTRUMENTS & EQUIPMENTS

6. • Good knowledge in Microsoft Office Tools.
• Labware LIMS, SQL LIMS and Stability Chamber Management Software
(ICDAS2.1).
Name : G.Sravan Kumar
Date of Birth : 17 June 1984
Marital Status : Married
Languages Known : English, Hindi, Telugu, Kannada and Tamil
Nationality : Indian
Address : Current Address:
G. Sravan Kumar
Flat No: 203, Meera Appartments,
TCP layout, Old Chandapura,
Hosur Main road, Bangalore,
Karnataka. Pin -560099
Permanent Address:
G.Sravan Kumar
S/o G.Parameswar Rao
H.No.23-1-688,
Sakhilamvari Street; Fathekhanpet
Nellore, Nellore District,
Andhra Pradesh. Pin – 524003
I am confident of my abilities to work in a team in a spirited manner to achieve
organizational goals. I hereby declare that the information furnished above is true to the
best of my knowledge.
(G.Sravan Kumar)
COMPUTER AND SOFTWARE SKILLS:
PERSONAL PROFILE:
DECLARATION:

7. • Good knowledge in Microsoft Office Tools.
• Labware LIMS, SQL LIMS and Stability Chamber Management Software
(ICDAS2.1).
Name : G.Sravan Kumar
Date of Birth : 17 June 1984
Marital Status : Married
Languages Known : English, Hindi, Telugu, Kannada and Tamil
Nationality : Indian
Address : Current Address:
G. Sravan Kumar
Flat No: 203, Meera Appartments,
TCP layout, Old Chandapura,
Hosur Main road, Bangalore,
Karnataka. Pin -560099
Permanent Address:
G.Sravan Kumar
S/o G.Parameswar Rao
H.No.23-1-688,
Sakhilamvari Street; Fathekhanpet
Nellore, Nellore District,
Andhra Pradesh. Pin – 524003
I am confident of my abilities to work in a team in a spirited manner to achieve
organizational goals. I hereby declare that the information furnished above is true to the
best of my knowledge.
(G.Sravan Kumar)
COMPUTER AND SOFTWARE SKILLS:
PERSONAL PROFILE:
DECLARATION: