Engineer Quality Control

SWETHA TIWARI

*** ****** **, ********, ** *****, Ph.- 540-***-****, Email: *****@****.***

OBJECTIVE AND SUMMARY:

• A Biomedical Engineer with exposure to pharmaceutical and biomedical research seeking a position in a challenging environment.

• Strong communication skills while working with different departments at various levels and ability to maintain positive relationships internal, external, independent, and team environments.

• Ability to multitask with a goal-oriented working style.

• Demonstrated good leadership skills when required, recognized problems and implemented strategies to strategically improvised them.

• Experienced in the interpretation and statistical analysis of pharmacokinetic and bio-analytical data with knowledge of Minitab, Winnonlin.

• Knowledge of HIPAA and HITECH act.

• Intensive knowledge of the principles involved in the pharmaceutical and biomedical fields.

• Familiar with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations, USP, CE markings requirements, ISO standards, 21 CFR, 510(k) submissions and premarket approvals for medical devices, GCPs and experienced in working under cGLPs and cGMPs standards.

• Knowledge and Understanding of CAPA, Lean Six sigma concepts in prevention or elimination of defects and variability in a process.

• Proficient at following SOPs and maintaining files and documentations well organized.

• Creative, proactive self-starter with integrative thinking skills with capability of initiating, leading, and successfully completing scientific projects with strong problem solving ability.

• Leadership skills in managing the supplier, market analysis, project management, facilitation and training end users.

EDUCATION:

• Master of Science in Biomedical Engineering Dec 2011

New Jersey Institute of Technology, NJ, USA GPA: 3.7

• Bachelor of Pharmacy July 2009

Nizam Institute of Pharmacy, JNT University, Hyderabad, India First Class-Distinction

TECHNICAL SKILLS:

• Laboratory Skills:

Gained Laboratory experience on techniques - DSC, TGA, SEM, Electro-spinning, TLC, Column Chromatography, Gel Electrophoresis, RNA/DNA PCR techniques, UV Spectroscopy, PH Meter, Gas Chromatography (GC), HPLC (Waters), Water determination by KF, impurity assays, density determination of powders, USP Dissolution Apparatus 2, Aseptic techniques, Acid-base titrations, assay by titrations, Viscometer, Paper Chromatography and Flourimetry.

Familiar with pharmacokinetics, in vivo drug metabolism studies, FACS, ELISA and maintained Good Laboratory Practices.

• Computer Skills: NIIT Certificate – “Programming in C and Data Structures”.

Software : MS-Office suite, MATLAB, CAD, PRO E (Wildfire 4.0 & 5.0), Empower2, Minitab.

Operating Systems : Windows Vista/W7, Mac OSX.

EXPERIENCE:

Research Assistant

Medical Device Concept Laboratory

New Jersey Institute of Technology, NJ, USA Aug 2010 – Dec 2011

• Managed and worked on various research projects

• Maintained various accounts and conducted surveys.

• Performed literature reviews utilizing the literature search engines and Internet.

• Understood the laboratory quality standards to ensure quality and accuracy.

• Experienced in labeling, processing, preparation and storage of various chemicals and reagents as required.

• Experienced with documentation of laboratory data and maintaining a lab notebook.

• Updated and wrote Standard Operating Procedures (SOPs) and standard protocols for the laboratory.

• Underwent safety training as per the standards of Occupational Safety & Health Administration (OSHA).

Pharmacokinetic Intern

Perrigo Company, NJ, USA Jun 2011 – Sep 2011

• Reviewed, analyzed pharmacokinetic data and prepared reports.

• Reviewed in-vitro release profiles and perform model – dependent analysis.

• Worked on recording the data and maintaining the database for pharmacokinetic R&D.

• Summarized literature for supporting BCS based Bio-waiver and ANDA submissions.

• Coordinated as well as interfaced with analytical and formulation departments to understand outliers/defects and assist in the development of new chemical entities and/or formulations.

• Worked on different projects and statistically analyzed data to determine Cmax, AUC, IVIV-Correlation, etc., using MS Excel.

• Experienced in calibration of analytical instruments and their routine maintenance.

• Attended cGMP training and seminars organized in the company.

• Reviewed Bio-analytical validation report in accordance with the FDA Guidance for Industry.

• Prepared buffers and media.

• Worked on acid resistance assay, Impurity assay using HPLC (Waters) and Dissolution of drug using USP Dissolution apparatus 2 in compliance with the SOPs and USP.

• Understood the drug-drug interactions, transporter mediated drug absorption and its kinetics.

• Exposure to the working environment in a generic company and the importance of meeting the customer’s standard of quality.

• Participated in day-to-day support management of critical/escalated issues.

• Participated laboratory quality control to detect and reduce deficiencies in analytical processes.

• Facilitated responses to and resolution of Severity Level 1 service request.

• Participated in facilitating root-cause analysis of Severity Level 1 problems.

• Provided recommendations on timing of software upgrades.

• Conducted a monthly review of support activity and other matters related to support of the customer’s environment.

Trainee

Sarvottam Care Ltd, Hyd, India May 2008 – June 2008

• Underwent industrial training for one month.

• Worked closely with the manufacturing unit as well as the quality control units.

• Performed quality control assay by titrations of the products as per the IP and USP requirements.

• Conducted laboratory practices in accordance with the cGLP while working on the qualitative analysis, UV spectroscopy, Auto-Titrator, HPLC, Dissolution apparatus, etc.

• Maintained accurate records of the qualitative analyses of the various products.

• Trained in the various processes of warehousing like receiving, order preparation, inventory management, etc.

• Demonstrated good team spirit and worked as an integral part of the team.

Laboratory Assistant

Nizam Institute of Pharmacy, Hyd, India Jan 2006 – Mar 2007

• Synthesized and purified various organic & inorganic compounds.

• Monitored and maintained the safety standards in the laboratory.

• Independently maintained, monitored lab equipment, inventory and ordered chemicals, other related supplies for laboratory.

• Estimated and assayed organic and inorganic compounds by titrimetry and characterized using UV-VIS.

RELEVANT COURSEWORK:

Biomaterials, Orthopedic Medical Devices, CAD (PRO E) for Ortho Implant, Validation and Regulation-Pharmaceutical Industry (FDA and EMA Regulations for Pharmaceutical and Medical devices), Principles of Neuromuscular Engineering, Computational Methods in BME, Nano materials, Medicinal Chemistry, Pharmaceutical Chemistry, Biochemistry, Biotechnology, Microbiology, Pharmacology, Pharmaceutical Analysis.

ACADEMIC PROJECTS:

Master’s Thesis – “Utilization of active PLLA-Soy protein Nano fibers blend for drug delivery of Nardsostachys Jatamansi” – NJ, USA

• Nardostachys Jatamansi is known to improve memory and is also used for the treatment of Parkinson’s disease.

• Extracted the drug using the Soxhlet Apparatus.

• Developed and characterized PLLA- Soy protein blend nanofibers with the drug containing the drug using DSC and TGA.

• Qualitatively investigated the nanofibers using Scanning Electron Microscope (SEM).

• Determination of the drug content in the nanofibers using UV Spectroscopy (Genesys 6).

Effect of hydro-alcoholic extract of Nardostachys Jatamansi root in ameliorating the symptoms of haloperidol induced catalepsy in rats – Hyd, India

• Studied the activity of hydro-alcoholic extract of Nardostachys Jatamansi alone in the haloperidol induced catalepsy in rats

• Orally administered the drug to the rats and analyzed them for acute toxicity as well as repeated oral toxicity studies.

• Examined the effects of repeated oral treatment on the blood parameters using Haemoglobinometer, Haemocytometer.

• Compared the anti-cataleptic activity of L-dopa and Carbidopa combination with the Hydro-Alcoholic Extract of the Nardostachys Jatamansi in haloperidol-induced catalepsy using metal bar test and block method.

“User Requirement Specification”

• Documented User Requirement Specification (URS), traceability matrix, drafted qualification test (IQ, OQ, PQ) and their acceptance criteria following the validation master plan.

• Prepared Strategies and parameters for the analytical method validation.

Project article on “Silica nanoparticles – As Drug Delivery Systems”

• Conducted literature survey and studied the recent advances in silica nanoparticles.

• The article served as a review of the benefits and challenges involved with the use of silica nanoparticles.

Principles of Neuromuscular Engineering – EMG: MATLAB

• Collected EMG signals using the electrodes and gathered data using MATLAB script.

• Compiled the data and filtered the data with a developed MATLAB program.

Computer Methods in BME – MATLAB

• Developed a 3D-Matlab program for American Sign Language interfacing MATLAB and VRML to display the alphabets and the numbers in the American Sign Language.

• Wrote MATLAB program interfacing with VMRL to display the mentioned character on screen.

CAD – Pro-Engineer (Wildfire 4.0) -“Total Knee Replacement system

• Studied the design specifications and the literature to conceptualize and design Total Knee Replacement system using about 25 features.

• Presented a PowerPoint presentation on the design and its characteristics along with comparison to the current implants available.

CAD – Pro-Engineer (Wildfire 4.0) -“Total Hip Replacement system "

• Conceptualized, executed, designed Total Hip Replacement system after surveying the present designs using approximately 20 features in CAD and analyzed the design using FEA and studied the biomechanics involved in designing an orthopedic implant.

LEADERSHIP/ACHIEVEMENTS:

• Secretary of the Indian Student Association- Sanskar at NJIT, New Jersey. (Fall 2010 – Spring 2011)

• Managed a budget of $7000.00.

• Organized about 20 events at New Jersey Institute of Technology, actively hosted and participated in the events.

• Scheduled meetings and maintained a record of the information discussed or finalized.

• Communicated and Co-ordinated with other members via emails and phone calls.

• Student Ambassador for the Office of International Students at NJIT, New Jersey, USA. (Spring 2010)

• Class Representative for 4 years at Nizam Institute of Pharmacy, India. (2005-2009)

• Discussed the complaints/issues of the students and put them across accordingly to the management

• Monitored 60 students for abiding by the rules of the Institute.

• Actively organized industrial visits and recreational tour.

• Surveyed literature, consulted neurophysician and medical professionals, successfully submitted a report and presented a seminar on “Parkinson’s Disease” at Nizam Institute of Pharmacy, India.

• Presented a poster on “Treatment of Infertility by Traditional Method: An Era of Alternate Medicine” at a Symposium held at the 18th annual meeting of Indian Society for the Study of Reproduction and Fertility (ISSRF), India.

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