Quality Control Assurance

Pradhyumna Garimidi, E-Mail: ************@*****.***

***** **** ** *** *** Mobile: 1-209-***-****

FREMONT, CA 94536

Total Work Experience:

One year (2020-2021) worked in Analytical validation.

About 8+ Years (2011-2019) of Pharmaceutical industrial experience in Dr. Reddy’s, worked in technology transfer department- analytical,

One year (2010-2011) in Quality control department.

JOB PROFILE:

Verification of Specification and STP for alternate Vendor (Documentation)

Preparation and approval of new documents Method Developments of various tests as mentioned below Validation of different tests and regular analysis of test batches.

Worked on method development Projects for the tests, Residual solvents by GC, Assay by HPLC & UV, Particle Size method by laser diffraction Technique, Related substances by HPLC, melting point by DSC and Dissolution by HPLC and UV.

Performed validations in the GMP area for different analytical procedures like Assay, dissolution, Related substances by HPLC and residual solvents by GC.

Verification of alternate vendor with Inhouse approved molecule by evaluating the critical parameters through feasibility analysis, vendor approved DMF, specification and STP.

Evaluating the Pharmacopeial compliance of the molecule with the respective market and coordinating with the inhouse regulatory department regarding the new alternate vendor to avoid the delays during the filing activities.

Preparation and calculation of Residual solvents declaration and Elemental analysis impurities if the limits are within controllable level.

Performed Investigation analysis for alternate vendor development molecules in case of discrepancies during the Exhibit, stability batches and Vendor samples.

Performing Analysis for Process Development samples (Trail Batch analysis, open Exposure study analysis, Performing Multimedia Dissolution and Dose Dumping Studies).

Installation of new Analytical lab Facility by Performing Installation and Performance Qualification for Analytical Equipment’s like Waters HPLC, UPLC and Dissolution Apparatus etc.

Trained new Trainees /Freshers in the Analytical lab by guiding them the instrument handling Techniques and analytical techniques.

Academic Profile:

Academic Qualification:

Post- Graduation in Pharmaceutical analysis and Quality Assurance in 2015 from Avanthi Institute of Pharmaceutical Sciences.

Exam Passed

Institution

Year of Passing

M. Pharmacy

A.I.P.S (JNTU)

2015

B. Pharmacy

S.V.C.P (Osmania University)

2009

Intermediate

Narayana Junior College

2005

SSC

Bhashyam Public School

2003

Presentations and Seminars:

Paper Presentation at PHARMAQUEST 2K9 on” Melt Granulation” at National Level Symposium held in Markapur.

Soft Ware Skills:

Packages (MS Office), Operating Systems (Windows)

Extra-Curricular activities

1.Had my presence at educational activities organized by “SSSS organization” and bagged Third Prize in Essay Writing

2.Received an Excellence Recognition in Initialization and Completion of Pace Projects in Dr.reddys Organization.

Personal Profile:

Marital Status : Married

Date of Birth : 22-06-1987

Nationality : Indian

Sex : Female

Languages : Telugu, English, Hindi

Strengths : Good Communication Skills, Ability to work with CFT’S,

Team Work, Self Confidence and Positive attitude

Thanking You

Yours sincerely

Pradhyumna. G

.

Contact this candidate