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Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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Professional Summary
• Over 13 years of working experience in maintenance of Lab Animal Facility, Health monitoring of
experimental animals, Regulatory / Pre-Clinical Toxicology, Clinical Studies, Preparation of Protocol,
Report reviewing and practical knowledge in the areas of Molecular Biology, Protein Chemistry, Tissue
Culture Immunology and Histopathology.
• Experience in laboratories with highest of standards, like class 10000
• Strong Practical knowledge on Regulatory / Pre Clinical Toxicology and Clinical studies.
• Good experience in making animal models for various diseases
• Highly committed to a career in a research environment
• Have the ability to lead projects involving a large team
• Extensive experience in handling routine laboratory matters
• Motivated, Dedicated and Objective oriented
• Strong interpersonal communication skills
Experience Profile
• Designing, monitoring and coordinating GLP and non -GLP (Bio Availability, Bio Safety etc.) Pre
Clinical Studies, which includes
Working closely with PSD Department
General Toxicology (acute & repeated dose)
Carcinogenicity
Reproductive Toxicology and Teratology
Genetic toxicology / Mutagenicity
Safety Pharmacology
General Pharmacology
ADME (Pharmacokinetics)
• Other Services
Acting as a Coordinator for NABL accreditation process
Preparation and review of SOP
Peer review services
FDA GLP, EPA GLP, OECD GLP, FDA, EPPA OPPTS and ICH guideline compliance
monitoring
Staff training for SOP reviews and GLP training
Updating of existing TOX summaries
Preparation of MSDS
Having experience in auditing national and international laboratories.
Organization: Bharat Biotech International Limited(June2005-Sep2007)
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Dr. R. Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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Duration: 2006 – SEP 2007
Location: Hyderabad
• Randomized controlled trial (RCT) design, the development and validity of trial randomized allocation
procedures.
• Development and review of selected clinical research protocols and other study related materials
conducting field site evaluations, training and advising field research staff in operational aspects of
Clinical Studies.
• Responsible for developing data management plant preparation, case report form development and data
entry system development to clinical sites as appropriate.
• Responsible for data management of over 18 clinical trials performed using GCP.
• Establishing Toxicology Lab as per GLP norms: Establishing Hematological, bio-chemical, Immuno-
toxicity, Genotoxicity and Histo-pathological labs as per GLP norms.
• Maintenance of animal facility as per the GLP guidelines: Health monitoring of lab animals and
implementation of all SOPs as per GLP.
• Designing and execution of toxicological studies: To evolve protocols for Pre-clinical toxicology as per
the guidelines of DCGI and OECD and ICH for various therapeutic molecules and executing the study.
• Documentation of Study Report: Preparation of final study report to be submitted to DCGI and DBT
for approval prior to clinical studies.
• To augment animal research capabilities and facilities in the organization as an facility in-charge.
• To extend research support for Animal toxicology experiments for various projects in the organization.
• Connected to R&D as Research project director for two molecules (name of the projects are
confidential).
Title/Position: Scientist (In charge Animal house and pre clinical toxicology
Flat No. 102, Moti Apartments, Opp Andhrayuvathi Mandali, Bharkatpura, Hyderabad, A.P, INDIA
Pin code: 500 027
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Dr. R. Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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Duration: 2005 to 2006
• Establishment of SPF Animal fertility single handedly India Ltd. according to SOP’s of Switzerland.
Design and Construction: Designing of the animal house has been done as per the latest GLP
guidelines. The key features of the facility are
Rooms for different animals
Flooring walls and ceiling of the rooms
Clean & Dirty Corridors with different entry and exit prints.
Quarantine Room: Fumigation Room; Pathology & Clinical Lab.
Differential / Pressure Zones
Air Conditioned and Filter air through animal specific air handling units.
Separate access for maintenance personal.
Light change control
Air shower: change rooms, wash rooms; store room etc.
SOP’s Validation: The GLP’s compliance maintained with various Standard Operating Procedures
(SOP’s) and validation procedures that ensure systematic operations include.
SOP’s for Transport: Quarantine and handling, maintenance and disposal of animals (culling).
SOP’s for experimentation and generation, stock, sample inward, animal feed, animal
weaning, animal coding.
SOP’s for microbiological procedures to monitor the health condition.
Validation procedure for compliance monitoring, temperature, humidity, number of air
change, sterility, particle counts, filter integrity, light intensity etc.
• Carrying out toxicology studies for each and every product which is under development which further
goes for clinical trials.
• Designing of protocols for various toxicological studies according to OECD / Schedule ‘Y’ guidelines.
Major R&D Project - General aspects of reproductive tissue and analysis of Histological and Histochemical
studies.
Flat No. 102, Moti Apartments, Opp Andhrayuvathi Mandali, Bharkatpura, Hyderabad, A.P, INDIA
Pin code: 500 027
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Dr. R. Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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• chromatography, gel filtration chromatography, gas liquid chromatography (GLC)
• Morphometrical studies of helminth parasites
• Ecology and Measurement of helminth parasites
• Practical experience in electrophoresis
• Standardization of serum haemotology (Immuno haemotology)
Flat No. 102, Moti Apartments, Opp Andhrayuvathi Mandali, Bharkatpura, Hyderabad, A.P, INDIA
Pin code: 500 027
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Dr. R. Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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∗ National Workshop on Environment and Stress: Sponsored by the UGC-DRS Scheme. Participated
in the workshop conducted in Department of Zoology from 9th Mar - 11th Mar 2000.
∗ 85th session of Indian National Science Congress from 3rd Jan - 7th Jan at Osmania University
Hyderabad: Participated as volunteer and contributed to the best of my ability.
∗ National Workshop on stress and Homeostasis: Sponsored by UGC-DRS Scheme.
Participated in the workshop conducted in Department of Zoology from 29th Mar - 30th Mar
2001.
∗ R.Rajani Devi, Dr.J.Venkatanarsaiah: Histopathology of gut of Channa striatus (Bloch) infected with
Neocamallanus singhi ali, 1956.
∗ R.Rajani Devi, Dr.J.Venkatanarsaiah: Haemotology of Channa striatus (Bloch) infected with pallisentis
ophiocephali (Thaper, 1930) Baylis, 1933
Flat No. 102, Moti Apartments, Opp Andhrayuvathi Mandali, Bharkatpura, Hyderabad, A.P, INDIA
Pin code: 500 027
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Dr. R. Rajani Devi
Mobile: +91 9618716846
Phone No : 040 - 27555735 Email: rajani_devi2006@yahoo.com
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∗ R.Rajani Devi, Dr.J.Venkatanarsaiah: Ecology and Measurement of
Neocamallanus singhi ali, 1956
Teaching Experience
• Worked as a part time lecturer for post graduate students. Department of Zoology, Osmania University,
Hyderabad from 2000-2003.
Title of Thesis
• Studies on some Ecological and pathological (Histopathology and Haemotology) aspects of Nemotodes
and Acanthocephalans of fresh water fish, Channa striatus (Bloch).
• M.Sc (zoology in first division) with parasitic physiology, acquaculture, sericulture, biochemistry,
animal physiology, embryology, cell and molecular biology, genetics and biometry as main papers.
Flat No. 102, Moti Apartments, Opp Andhrayuvathi Mandali, Bharkatpura, Hyderabad, A.P, INDIA
Pin code: 500 027
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