Quality Assurance Control

PHONE NO: 088********

OBJECTIVE

To work with a FDA regulatory organization, engaged in continuous learning and scientific development that can provide me a platform to exploit my skills and further contribute my share of responsibility.

To participate in a short, medium or long-term projects within the FDA regulated industries on Quality Control, Quality Assurance, NDA/ANDA (CMC section) Preparations, Calibrations, Workflow Analysis and Efficiency Enhancement Projects.

SKILLS

Familiar with various manufacturing processes, process and cleaning validation, documentation system, SOP’s, cGMP, GLP, and cGCP as well as NDA/ANDA (CMC Section) preparations and reviews and FDA regulations.

Well versed in all modern instrumentation such as HPLC,HPTLC, DT, UV, IR,KFR, RMR, Polari meter, TLC Visualizer and Auto titrate as well as various other analytical techniques.

Experience in various dosage forms in control batch analysis such as tablets (I.R. and M.R.), capsules, creams, liquids, suspensions, gels products.

Well versed in generation, maintenance and revision of SOPs.

Excellent interpersonal, communication skills.

Wide exposure to quality control and knowledge of quality assurance. Proficient with common computer software.

I.T SKILLS

Applications: MS Word, MS PowerPoint, MS Excel

Operating Systems: Windows 7, Windows XP, Linux

EMPLOYMENT

Working as QA/QC Executive in Himalaya drug Company since March 2015.

RESPONIBILITIES/DUTIES

Working as chemist, performing analysis of pharmaceutical products and finished products.

Responsible for activity of the Quality Control/Quality Assurance of finished and semi-finished goods.

Analytical method development and validations using UV and HPLC.

Maintenance of SFG records, calibration record for DT and pH.

Instrumentation operation: KFR apparatus, UV, HPLC, Auto-titerator, Polari meter, RMR, Sieve shaker, HPTLC.

Preparation of Volumetric flask and standardization of chemicals reagent

EDUCATIONAL PROJECTS

2015 Simultaneous Estimation of Norfloxacin and Tinidazole and their Cross Validation from Acharya College of Pharmacy, Bangalore

EDUCATION

Masters in Pharmacy in QA/QC from B. Reddy College of Pharmacy, Bangalore in 2015.

Bachelor in Pharmacy from B. Reddy College of Pharmacy, Bangalore in 2013

Senior Secondary School from P.M.H.S, Patna, Bihar in 2009.

Secondary School from Woodbine Modern School, Darbhanga, Bihar in 2007.

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