V.G. Shashi Vardhan is seeking a challenging position in an organization where he can improve his knowledge and skills. He has over 8 years of experience in quality assurance and microbiology roles at pharmaceutical companies. His responsibilities have included auditing, validation, documentation, environmental monitoring, method development, and ensuring compliance. He is proficient in various instruments and has participated in regulatory audits. He holds an M.S. in Microbiology and has undergone training in areas such as GMP, team building, and auditing.

1. CURRICULUM VITAE
V G SHASHI VARDHAN Mobile no: +919676955399
E-mail: vg.shashivardhan@gmail.com
Career Objective:
I seek a challenging position in the organization, which progresses dynamically and give me a
chance to improve my knowledge, enhance my skills and be part of the network towards the
growth of the organization. To achieve personal and professional excellence in diverse and
challenging environment.
Work Experience:
1. Acacia Life Sciences Pvt. Ltd., Vishakhapatnam as Asst. Manager Quality Assurance
and Microbiology from February 2014 to till date.
2. Integrated Global Regulatory Services Pvt. Ltd., Bangalore as Executive-
microbiologist from April 2013 to February 2014.
3. Kemwell Biopharma Pvt. Ltd., Bangalore as Executive QC- Microbiologist from Sep
2010 to April 2013.
4. Provimi Animal Nutrition India Pvt. Ltd., Bangalore as QC- microbiologist from
August 2007 to August 2010.
Training:
Worked as part time paid trainee during November 2005 to July 2007 in Tetragon Chemie
Pvt. Ltd., Bangalore.
Current Job responsibilities:
About company: Acacia Life sciences Pvt. Ltd. is an Active pharmaceutical manufacturing
company situated at Vishakhapatnam, India; it is established in the year 2008. And recently the
company audited and approved by USFDA where I was part of lead auditee team. Common job
responsibilities listed below:
Co-ordinate with all department heads in the plant for smooth functioning of systems
Assist in investigation and identifying root causes for process deviations and customer
complaints. Propose appropriate Corrective & Preventive Actions and ensure timely
implementation of CAPA.

2. Documenting the complaint history i.e. from the registration of complaint to the responses
(Establishing the preventive and corrective action plan) forwarded to the customer and
implementing the feasible recommendations of the customer.
Performing the self inspections among the departments
Prepare and review of validation protocols for process, qualification of equipment and
facilities etc., close monitoring during execution of validation batches and approve validation
reports.
Coordinating in the trial and validations in order to have control over the process and to fix
the optimum parameters and review the validation protocols and validation reports.
Prepare and review written procedures, specifications, processes and methods as per the
current regulatory/pharmacopoeia standards and requirements.
Compilation and Review of Annual review reports for tracking the history of the product
manufactured in that particular year.
Compilation of General Annual review to coordinating the general systems.
Review the Vendor documents before qualified the vendor.
To track history of the changes coordinates in implementation of change control system.
Handling of Planned deviation reports and implements corrective and preventive action.
Perform weekly, monthly reports and conducting MRMs as per schedule.
Regulatory filings like submitting necessary documentation for DMFs/CMC & deficiencies
response.
Review the Certificate of Analysis and checking the details stated in delivery order during
finished product dispatch.
External laboratory audits and compliance report reviewing.
Cleaning validation protocol preparation, Execution and reviewing of documentation.
Overall monitoring of Microbiological activities, Indenting, follow-up of materials & other
departmental needs.
AHU qualification of microbiology lab with required documentation.
Required Microbiology instruments/equipments procurement and qualification of the same
with complete documentation.
Conduct training programs to working personnel on cGMP/ cGLP/ SOP’s etc.
To track and approval of system documentation such as Change control, planned deviation
and unplanned deviations.
Previous work Experience:
Totally having more than 8 years 11 months of experience in the pharmaceutical industry, having
confidence of handling instruments and can participate in activity of QA & QC. And some of my
routine activities are highlighted below.
Water Monitoring – Analysis of Raw water, Treated water and Purified water as per USP
procedure.
Raw material sampling.

3. Antibiotic assay – Bacitracin, Polymyxin B sulphate and Neomycin Sulphate.
Raw material and finished product analysis for Microbial limit test.
Environmental monitoring – by Active and Passive air sampling methods.
Pure culture maintenance.
Cleaning validation and Hold Time Study for the uncleaned equipments.
Handling of system compliance and Audit compliance activities.
Growth promotion test for the media.
pH meter calibration and maintenance.
Protocol preparation for GPT validation, MLT validation, Disinfectant efficacy test
validation etc
SOP preparation and reviewing for compliance.
External Laboratories audit and Compliance report checking for the same.
Audit Exposure:
Involved in USFDA, EMEA.
Involved in Novartis, Johnson &Johnson, TEVA, Cipla, GSK audits and Mylan audits.
Involved in Customer audits like Actavis, Orion pharmaceutical ltd., Orchid pharmaceuticals,
Pfizer, Boehringer Ingelheim, Merck etc.
Involved in Ukraine regulatory audit.
Instruments Handled:
Gas Chromatography.
High Performance Liquid Chromatography.
HPTLC
Atomic Absorption Spectroscopy.
Near Infrared Spectroscopy.
UV spectrophotometer.
pH meter calibration and maintenance.
TOC calibration and maintanance.
Training Undergone:
5’s Housekeeping training.
Team Building.
Accredited with “GMP approved auditor”.

4. Educational Qualification:
Master of Science : 2007
Area of specialization : Microbiology
University : Bangalore University, Bangalore.
Bachelor of Science : 2005
Area of specialization : Microbiology, Bio-chemistry & Zoology.
University : Bangalore University, Bangalore.
Personal Profile:
Father’s Name : V.R. Govind Kumar
Date of Birth : 16-Aug-1984.
Permanent Address : #01, Block No. 01, S HIG C,
5th
Phase, Yelahanka New Town,
Bangalore - 560064.
Present Address : #404, Sai Nithya apartment - 2, Kurmannapalem, Gajuwaka,
Vishakhapatnam – 530046.
Languages known : Sourashtra, Kannada, Hindi, English and Tamil.
Hobbies : Playing Chess, Carom and Embroidery.
Declaration
I declare that the information furnished above is true to the best of my knowledge,
Yours sincerely,
(V.G. SHASHI VARDHAN)