Project Manager Quality Assurance
Resume:
LAKSHMI PRASANNA. PALLE
Fresh Meadows, NY-11366
Cellular: 718-***-****
E-mail: *************.*****@*****.***
CAREER OBJECTIVE:
To learn and gain experience in the regulatory field and to carve a niche for myself in the professional serving field of the Pharmacy as a Global Regulatory Affairs Consultant.
EDUCATION PROFILE: St. John’s University, College of Pharmacy and Allied Health Professions, New York, Masters in Regulatory Affairs and Quality Assurance (Jan 2011-Dec-2012) Current term GPA - 3.90.
Relevant Courses: Introduction to Regulatory Affairs, Product Labeling, International Drug Regulatory Affairs, Regulatory Submissions and drug approval procedures, Good Manufacturing Practices for Pharmaceuticals. RBVRR Women’s College Of pharmacy, Osmania University, India. Bachelor’s in Pharmacy (June 2006- May 2010) GPA - 3.89. Board of Intermediate Studies, School of Sciences, Majors in Biology, Physics and Chemistry (Bi.P.C) GPA – 4.0.
RELATED WORK EXPERIENCE:
St John’s University, MS in regulatory affairs (January 2011-December 2012) Working on a project, “Design Strategies for cGMP compliant labs and Facilities for drug manufacturing companies” with my professor Dr.Edwards. Also working on a project, “Product Labeling for Pediatric Drugs” with another professor of mine, Dr.Gamper. Masters program made me efficient and skillful with various branches of U.S Regulations under the guidance of my professors who are regulatory professionals themselves: Product Labeling- learnt the various aspects of labeling rules and regulations. Worked on project for making a Prescription label for the drug Medrol using the labeling guidance. Regulatory submissions- Worked on the project for preparing INDA and NDA for the drug product linagliptin using the guidance’s and CFR 21 and also worked on IDE’s and PMA’s for medical devices. Good manufacturing Practices-Worked on Responding to a warning letter from FDA for a pharmaceutical company and learnt the good manufacturing Practices for Pharmaceuticals. International Global Regulatory Affairs: Learnt about various global regulatory bodies and worked on comparing the medical device law and regulations of USA, Japan & EU and the IVD devices for USA and Canada.
Internships (May - July 2009): Worked as an Intern in the R&D department at Shantha Bio-Tech a Parenteral Industry which is a part of Sanofi Aventis Group. Assisted the QC and QA groups as a part of curriculum. Practiced techniques including protein quantification by Lowry Method, Western Blotting, and SDS-PAGE as a part of the training. Also volunteered research work over the Monoclonal Anti-Bodies for Cancer treatment.
LAKSHMI PRASANNA. PALLE
158-04, 79th Ave,
Fresh Meadows, NY-11366
Cellular: 718-***-****
E-mail: *************.*****@*****.***
Training: Attended a workshop on “Techniques and Instrument Applications in Pharmacy” organized by Ventura Bio Sciences, Hyderabad and also worked as a Research Assistant at Ventura under the guidance of the Associate Scientist Mr.L.N.Reddy.
o Learned the handling of Instruments like UV & IR Spectrophotometers.
o Studied in detail the HPLC technique and other Chromatographic Techniques.
o Well acquainted with the Polymerase Chain Reaction (PCR) Technique, Gel electrophoresis and Protein purification Techniques. Worked as a Teaching Assistant (September 2009-March 2010) at the Community Pharmacy Practice department and have done research on Communication Theories in Clinical Practice, Patient Counseling and Medication History Review and conducted seminars to the junior year students. Worked as a pharmacy technician at a medical hall, and was trained to be a pharmacist and have gained enough experience to work in a pharmacy. Participated in the Indo-American Pharmaceutical Regulatory Symposium organized by College of Professional Studies, North Eastern University, Nalgonda, India.
ADDITIONAL WORK EXPERIENCE:
Information Technology - Classroom Support (August 2011- Present) Work in the audio-visual department. Set up IT equipment during events at school. Involved in trouble shooting of issues related to the IT equipment in the classrooms. Answer the phone calls.
Student Ambassador - Conference Services, St.John’s University (Summer 2011) Represented prestigious St.John’s University as an Ambassador. Guided students from Italy to learn English during their ESL course. Worked as their guide in New York City while they toured the city. Took care of all their needs and planned their schedule for each day.
Information Technology - Conference Services (May, 2011) Troubleshoot the hardware problems regarding the desktops and laptops. Involved in the PC maintenance and the issues related to the computers and laptops. Dealt with WI-Fi- Connectivity Issues. Checked and fixed connectivity issues in the dorms.
Architecture & Design Department, St.John’s University (January-April 2011) Updated the Floor Plans. Entered the updated data into the Excel sheets and word documents. Corrected the designs and edited them. Drew revised floor plans.
LAKSHMI PRASANNA. PALLE
158-04, 79th Ave,
Fresh Meadows, NY-11366
Cellular: 718-***-****
E-mail: *************.*****@*****.***
Event Management Staff, St.John’s University. (September 2010-December-2010) Organized equipment required for the events held at school. Arranged the Computers, projectors and the audio system required for the events. Assisted the students in directing them to their right classrooms.
COMPUTER SKILLS:
Familiar with MS-Word, Excel, PowerPoint, Access, SQL and with bio-informatics software like GenMAPP and BLAST.
EXTRA CURRICULAR ACTIVITIES: Captain of the College Throw Ball Team and lead the team at various Inter-College Competitions. Conducted workshops on Graphology and attended workshops over personality development. Member of the youth wing of The Art of Living Foundation called the World Alliance for Youth Empowerment. Underwent special training programs provided by the Art of living foundation like Yes! +, DSN workshops. Volunteer for the international workshop called Youth Empowerment Skills Workshop (yes! +).
REFERENCES:
1. Dr.Somnath Pal, Professor, Pharmacy and Administrative Sciences, St.John’s University- ****@*******.***.
2. Corinne L.Gamper, Faculty, Pharmaceutical Administrative Sciences (PAS) Department, St.John’s University - *******@*******.***.
3. Candis B. Edwards, Part-Time Faculty, Pharmacy and Administrative Sciences, St.John’s University, ********@*******.***.
4. Arsenio Cepin, IT Project Manager, Classroom Support & A/V Services, St.John’s University, ******@*******.***.
5. Erin P. McDonnell, Director of Operations for Conference & Auxiliary Services, St.John’s University, ********@*******.***.
6. Jonathan Ranola, Project Manager, Design and Construction, St.John’s University, *******@*******.*** .
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