Pharma Regulatory Affairs Executive : Resume CV

[dv82in]

SUMMARY :
- Over 2 yrs of experience in Pharmaceutical Research and development as
Scientist in
- Expertise in analytical drug development and Drug Regulatory affairs.
- Strong planning, analytical and problem solving skills.
- Excellent Written/Verbal communication skills. Experience in working
in a team and independently to resolve technical issues of a project.

EDUCATION :
- Completed M.Pharma in bulk drug technology with an Aggregate of 72% from Rajiv
Gandhi University of Health Science in the Year 2007
- Graduation B.Pharma from Mahatma Gandhi University in the year 2004

PROFESSIONAL EXPERIENCE :
- Have experience in Analytical method development of formulation and API.
- Conducted analysis of stability study of formulation and API, including impurity profiling.
- Conducted Method Validation studies.
- Various analysis comprising of solubility study by nephelometry, particle
size determination by zeta seizer, water content by Karl Fischer apparatus.
- Complete analysis of raw material.
- Preparing Standard Operating procedures and standard test procedure.
- Literature search for discovery molecules.

Instrument coverage :
- Shimandzu HPLC, Agilant RRLC
- Dissolution and disintegration apparatus
- UV Spectroscopy.
Operational knowledge of Spectrophotometer :
- Malvern Zeta seizer
- Karl Fischer apparatus, Columeter
- Nephelometer
- Autotitrator
- Franz diffusion cell
- Thermomixture
- Centrifuge.
- Viscometer

SPECIAL TRAINING AND SEMINARS ATTENDED :
- Received training on Drug Regulatory Affairs covering USFDA and EU Regulatory
-ICH Guidelines
-EMEA
-TGA.
- Attended seminar of Agilant,Waters on column and RRLC
- Seminar on Zeta Sizer

NATIONAL PROGRAMME :
Attended 3 Days Conference of IPC 2005, Hitec City,Hyderabad.

ROLES & RESPONSIBILITIES :
- Responsible for receiving sample from medicinal drug development dept
and formulation dept and conducting the analysis of the same.
- Responsible for trouble shooting of various instrument in the analytical dept
- Conducted training to the newly joined junior scientist on various instrument used in
the analytical dept.

INITIATIVES TAKEN :
- Internal process help to the formulation and chemistry dept
- Maintaining Daily Reports of the Team.
- Conducted seminars
- Splitting of work among associates.

STRENGHTS :
- Honest and Dependable with Excellent Interpersonal skills
- Good team player, listener and motivator.
- Good communication and presentation skills.
- Always believe in commitment and consistency.
- Highly self-motivated, Quick learner and proactive.
- Willing and able to handle wide variety of tasks simultaneously.

COMPUTER PROFICIENCY :
Working knowledge of Basics of computer, MS-office, Excel, Photoshop, Internet, etc.

PERSONAL PROFILE :
Date of Birth : 28 February 1982
Marital Status : married.
Nationality : Indian.
Language Known : English, Hindi, Malayalam, Gujarati

I hereby declare that the above given information is true to the best
of my Knowledge & belief,

Thanking you.

Deepti V Nair

[Guest]

SHOBHARANI.B
Email ID : shoba.bnl AT gmail.com

OBJECTIVE :
To hold a reasonable and respectable job in a specialised organisation which secures name and fame to me and our company.

EDUCATION QUALIFICATION :
Degree Name of Institute / University Year of Passing % Secured :
B. Pharm CES COLLEGE OF PHARMACY KURNOOL 2010 73
D. Pharm SPWP TIRUPATHI 2007 75.6
Intermediate (M.P.C) BHUVANAVIJAYAM GIRL’S COLLEGE NANDYAL 2005
84
X Class ZPH SCHOOL SIRVEL 2003 85

DISSERTATION WORK :
- Completed project work in kurnool , CES college of pharmacy
- “Solubility enhancement of aceclofenac by solvent evaporation method”

Project training Period : jan2010-april2010
Objective : To develop and evaluate solid dispersions of aceclofenac .By using PEG in formulation as a polymer to increase the solubility of poorly water soluble drugs like aceclofenac.There by we can increase the overall bioavailability of the drug.

ABILITES/ INSTRUMENTATION SKILLS :
- Experienced in performing lab formulations
- Have a good .knowledge in subject
- Operating of uv-vis spectroscopy, fluorimetry, dissolution apparatus, disintegration apparatus, hardness tester, friabilator,etc

COMPUTER PROFICIENCY :
- Post Graduation Diploma in Computer Applications (PGDCA)
NIIT in sirvel
Secured : 80%
Knowledge in : ‘C’ Language. MS DOS, Win MS Office,
Special skill in systemic analytical science (SAS) which is very important for analyzing purpose.