Quality Control Management

PANSY AWASTHY

**** **** *** ******* ** ***** C: 248-***-****, ****.*******@*****.***

Professional Overview

A Pharmaceutical Science major with a dual background of industry and hands on experience in research laboratory, which provided thorough knowledge of cGMP, GLP, FDA regulatory guidance, ICH, ISO and USP guidelines and requirements of ANDA submissions.

Looking for a challenging leadership position in research or quality assurance/control to learn the intricacies of pharmaceutical industry.

Summary of Skills

Pharmaceutical operations: Aseptic techniques, Research and Development (R&D), SOPs, CAPA, methods and instrumentation, developing protocols and formulation associated with pharmaceutical and cosmetic products.

Statistics: Statistical Program for the Social Sciences (SPSS), Excel and Epic software.

Quality Analysis and control: HPLC, NMR, UV, pH testing, water testing and Karl Fisher and auto-titrator.

Molecular Biology techniques: PCR, Sequencing, Gel Electrophoresis, DNA/RNA purification and extraction, western blotting, Time kills and Pharmacokinetic modals, MICs detection, and mammalian tissue culture.

Project management

Validation and Stability testing

MSOffice, LIS, SharePoint

Professional Experience

Student Research Assistant 09/2014 to 07/2015

Anti-Infectious Research Lab, Wayne State University College of Pharmacy, Detroit, MI

Assisted post-doc fellows in research projects, major one “Evaluation of combination antimicrobial therapy against bacterial biofilms produced by Staphylococcus aureus and Enterococcus sp “

Evaluated MIC90 breakpoints for tedizolid in comparison to other antimicrobial agents against drug-resistant Staphylococcus aureus and Enterococcus sp.

Provided research support by setting up pharmacokinetic models and pre-experimental setup.

Experienced in detecting minimum inhibitory concentration (MICs) of antibiotics and time kill experiments

Member of Management 09/2012 to 07/2013

Awasthi Group of Institutions, Nalagarh, India

Tracked financial status of the Institute analyzed statistically the data and cut down the expense by 5%.

Taught pharmacology and toxicology at School of Nursing.

Was involved in the development and management of Smart Laboratory for the institution.

Maintained and updated departmental affiliations and auditing documents.

Assigned tasks and projects to the team and direct staff in daily work assignments.

Internship

Summer Intern 06/2009 to07/2009; 06/2010 to 07/2010;

Alkem Laboratories Ltd, Baddi, H.P. India 07/2011 to 08/2011

Formulated Tablets, Capsules, Dry Powder, Injectable and Oral Suspensions dosage forms in General block (Penicillin) and Cephalosporin block.

Practiced quality and process improvement; using HPLC, GC, NMR, MS, Dissolution and Disintegration test.

Trained in QC testing of Safety, Quality, Compliance and efficacy according to FDA, MHRA, ICH, USP, BP, EP and JP guidelines.

Reports: (1) Microbial testing of pharmaceutical products and water analysis and water analysis

(2) Production and packaging of products in cephalosporin block, quality control department and general block.

Education

Master of Science: Pharmaceutical Sciences 2015

Wayne State University, Detroit, MI, USA (3.56 GPA)

Strong Felds of course work include Research and techniques, drug delivery, advance pharmacology, medicinal chemistry, pharmacokinetics, Biostatistics, Epidemiology

Bachelor of Science: Pharmaceutical Sciences 2012

Kurukshetra University, India (3.89 GPA)

Major Course work: Project Management, Microbiology, Chemistry of Natural Products, Forensic Pharmacy, Analytical Chemistry, and Pharmaceutics

Thesis/Dissertation

A retrospective cohort study of high prevalence of ST131 among extended spectrum of β-lactamase producing E.coli among inpatients in metropolitan Detroit area. 01/2014 to 07/2015

Compared the characteristics and clinical outcomes of patients with ST131 ESBL producing Escherichia coli infections and patients with non-ST131 ESBL producing Escherichia coli infections.

Used SPSS tools and logistic regression models to analyze and compare the clinical data of patients.

Concluded that there was no clinical significant difference between the two groups, although there was high prevalence of ST131 E.coli among the patient’s isolates.

Publication

Outbreak of Colistin-Resistant Acinetobacter baumannii in Intensive Care Units in Detroit, Michigan

Presented at Conference: IDWeek 2014 Meeting of the Infectious Diseases Society of America

Publisher: ResearchGate

Projects

A Systematic analysis of nephrotoxicity associated with Vancomycin and Piperacillin/Tazobactam DMC and Wayne State University 01/2015 to 05/2015

Nephrotoxicity and Creatinine levels were detected among the infected patients when vancomycin or piperacillin/tazobactam (zosyn) or combination was given and its prevalence was studied.

Clinical data and demographics of patients admitted from 2010 to 2013 were analyzed and reviewed.

Clinical studies of patients with UTI

DMC and Wayne State University 09/2014 to 12/2015

Prevalence of UTI among infected patients was analyzed and demographics were extracted from CIS DMC.

Outbreak of Klebsiella pneumonia (Multi-Locus Sequence Typing)

Wayne State University 01/2014 to 10/2014

Prevalence of Single nucleotide polymorphism in Klebsiella pneumonia had to be analyzed.

Techniques used: DNA extraction, PCR, Gel electrophoresis, Purification of DNA, Sanger sequencing.

Level of concentration of mitochondrial proteins

Wayne State University 07/2013 to 12/2013

Determined the levels of complex 1 & 2 in the methamphetamine treated rats

Techniques used: Western blotting, UV quantification, and protein extraction.

Performed Bioassays and obtained Dose Response Curve for various OTC drugs, assays were performed on frog's heart and rat's intestine 2012

Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, India

Contact this candidate