Project Quality Control

Manpreet Kaur

*** ***** ******

Harrison, NJ ****9

E-mail: *****@****.***

Mobile No: 973-***-****

Summary

A self-motivated, confident & goal - oriented professionally and practically experienced masters candidate seeks a

responsible career opportunity in which I can successfully utilize my technical professional and managerial skills

towards the set objectives with exceptional organizational ability and communication skills.

Core competencies

• Medical (Healthcare Professional) Inquiries

• Product Complaints

• Electronic Adverse Events Management System

• Clinical Data Management Systems

• Electronic Data Management Systems

• Activity Reports, as scheduled or requested by client

• Clinical and Technical documentation

• Generation of user specific reports.

• Periodic Safety Reports

• Integrated Safety Summaries

• MedRA coding cdd and WHO dictionary

• 21 CFR and Validation

• Developed Business flow diagrams, Activity diagrams and Sequence diagrams

• Develop customized business strategies that are aligned with corporate strategic objectives.

Certifications

Certified by Clonegen Biotechnology as Industrial hands on training in techniques of molecular biology

and pharmaceutics like HPLC, MS, GC, AA, HPTLC, with other Microbiology laboratory techniques and

procedures as PCR, enzyme assay, micro array, sterilization, solid and liquid culture mediums sampling,

sample collection procedures for bacteria and titrations etc

Certified AIIMS Pharmacist trainee with the following responsibility:

• Dispensing of drugs to the patients

• Update record register for patients and drugs

• Keep the inventory of drugs

• Consult with Doctors regarding the prescription drugs.

Certification of Appreciation for presenting a paper on Effect Of Nanotechnology On Humans in National

Conference on Nanotechnology and Beyond

Technical Skills

• Ability to use and perform HPLC( water aquity ultra performance LC), IR (perkin elmer 1930), UV-Vis, GC

(HP), GC/MS, LCMS, Chromatography, Aqueous/Non-aqueous titrations, AA (Coulter Counter), PCR,

HPTLC, Dissolution, Disintegration.

• Perform quality control stability studies

• Perform Sterility testing’s

• Write technical reports detailing procedures, outcomes and observations

• Proficient user of Oracle ARGUS 6.0.1, PFOENIX, ARisG, PL/SQL Matlab, Alchemy2000 and Spartan tools,

Window Professional OS

• Business Modeling Tools: Rational Rose, Rational Requisite Pro, MS Visio, MS Project

• Good knowledge of cGMP, GLP, FDA regulations, Eudravigilance, EMEA guidelines, MedDRA Levels, 21

CFR and Validation

• Solid ability to distinguish and grasp an understanding of the laws, rules, regulations, bargaining

agreements, and or business processes that relate to a business domain.

Academic Qualification

New Jersey Institute of Technology

Master of Science- Medicinal and Pharmaceutical Chemistry

Faculty of Pharmacy, Guru Gobind Singh Indraprastha University

Bachelor of Pharmacy

Professional Experience

BioNeutral Groups, NJ June2012- Present (12months)

Position: Product Development Associate Chemist

Roles and Responsibilities:

• Prepare Samples and Formulations using SOP

• Conducts general laboratory procedures, using Standard laboratory practices, Good Laboratory Practices

and Good Manufacturing Practices

• Perform Quality control testing as per the guidelines

• Perform periodic titration of samples, formulations

• Review and approve batch manufacturing records and batch releases

• Following and ensuring strict safety procedures, safety checks and safety guidelines ie EPA, ICH, FDA

• Maintain inventory of laboratory testing supplies to ensure appropriate levels of supplies

• Manage appropriate database and spreadsheets to accurately report and result

• Conducts routine laboratory maintenance, including reagent inventory, instrument calibration, and facility

monitoring

• Ensure that records, specifications and raw data are properly recorded, reviewed and retained

• Prepared final reports, detailing procedures, outcomes, observations, production summaries and other

written reports.

• Filing Product complaints and finding solutions depending on the type of complaint.

• Develop Business flow diagrams, Activity diagrams and Sequence diagrams for recommend potential

customers, sales force and suppliers for better understanding of product and marketing

• Work with QA team

• Prepare Labels for samples or marketed products

• Performing all other related duties as assigned.

Graduate Student Association, NJIT August2011-May2012 (9 months)

Position: Research Coordinator

Roles and Responsibilities:

• Coordinator between graduate students, department chair and graduate student association

• Conduct feedback sessions for graduate department students

• Take graduate students concerns and consult with concerned person

• Manage Graduate student database

• Solve Students queries and questions regarding department

• Participate in organizing events for graduate students

Wipro Ltd, Greater Noida, Uttar Pradesh, India Jan2010- Dec2010 (12months)

Position: Pharmacovigilance Officer for Pfizer USA

Roles and Responsibilities:

• Collect Medical Information/ Adverse Events from physicians, pharmacists, nurse and consumers via

faxes, calls or emails from USA,

• Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for

all ICSRs (Individual Case Safety reports) in order to determine whether there is an existing case file.

• Creating an electronic case report file for a new case.

• Prepared Adverse Event forms as per ICH and FDA guidelines,

• Prioritizing the adverse event reports processing base on the ICH dates.

• Performing verification of data and text authored by PSSR against sources, as well as verification of

internal consistency.

• Uploading medical information on global tools like ARGUS and PFOENIX, ArisG,

• Coding of medical history, drugs and reported adverse event terms in safety database using medical

dictionaries like MedDRA, and WHO-DRL.

• Thorough knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures.

• Good knowledge of computer validation and Part 11 requirements.

• Deciding the serious criteria of the case, Prioritize the event or case according to the applicable

guidelines.

• Performed narrative writing,

• Ensure integrity, accuracy and completeness of data

• Filing PQCs (product quality complaints) associated with adverse events.

• Performing quality review or authoring of regulatory submission documents and aggregate reports,

including verification of data and text

• Checking cases for discrepancies for any errors related to labeling and narrative writing.

• Setting up follow-up letter to the reporter for further case follow-up as per the applicable guidelines and

reporting the case to the respective regulatory agencies.

• Provided solutions to the consumers, physician, and pharmacist.

• Expedited reporting.

• Basic knowledge of Eudravigilance, EMEA guidelines, MedDRA Levels

• Provide inputs into periodic reports (PSUR, BR, AR, ASR, DSUR)

Panacea Biotech Ltd, Mohan cooperative, Badarpur, India May2008-Dec2009(1year 6months)

Position: Production/QC Analyst

Roles and Responsibilities

•Involved in the production of Tablets, Capsules, Syrups, Gels like formulations.

•Experience on some instrumental techniques like HPLC, IR, UV, GC, Mass spectroscopy.

• Assist in the organization of the Quality Control Laboratory

• Complete accurate analysis of raw materials, intermediates, bulk and finished packaged product in

compliance with authorized test procedures and relevant reference literature.

• Reporting and recording analytical results utilizing Quality Documentation systems as specified within the

company's Quality Manual.

• Performed quality control stability studies.

•Familiarized with concepts of Quality Assurance including GMP compliance, internal audit systems and

evaluating & implementing Standard Operating Procedures.

•Documentation of Certificates of Analysis, environmental monitoring data and evaluating batch manufacturing

records.

RANBAXY, GURGAON, INDIA April2007-April2008(1year)

Position: Validation Analyst Intern

Roles and Responsibilities:

• Developed the Validation Master Plan for ArisG Drug Safety Software.

• Developed IQ, OQ and PQ for instrument applications.

• Participated in all the phases of SDLC and involved in creating Validation protocols.

• Provided GAP analysis on incomplete SOPs, and added the required SOPs.

• Participated in the documentation review process and Document Review sessions.

• Developed Remediation Plan and Test Strategy for multiple Spectrophotometers using integrated system

strategy.

• Reviewed and developed Requirements Traceability Matrix (RTM).

• Involved in preparation of configuration documents in accordance to company standards. Assisted the team

with Validation Summary Report and release of instruments for production.

• Worked with Mercury Quality Center to update, report on, and maintain Test Sets.

• Worked with Oracle/SQL Clinical Validation suite to obtain a comprehensive view of important clinical data.

• Develop the QTP test automation suite and deliver for regression testing. Facilitate automated test execution

using Quality Center, create test batch and automated execution schedules. Assure test data, schedule

automated/manual tests.

• Involved in determining the current publishing process performed the gap analysis between the as-is and to-

be process.

• Review Validation Deliverables from the QA perspective using pharmaceutical GxP practices.

• Conduct QC of final project Validation Deliverables, electronic version and hard copy version.

• Recommend areas for remediation and review action plan.

Projects Handled

New Jersey Institute of Technology, USA

Project: Molecular Modeling Studies of Nicotinic Agonist

Project Description: Drawn and designed 11 nicotinic chemical structures individually with the help of Alchemy2000

and conformers were generated by comparing their relative energies, dihedral angles and plotting graph. Bioactive

conformers were chosen and superimposed with RMS-Fit technique given agonist by the help of SPARTAN tool and

electrostatic potential density map study were done to conclude which molecule is having similar potency as of the

template conformer.

Project: House Project

Project Description : Decided the house description like 3BHK with 2baths and etc then what work has to be done to

built it with work breakdown structure and work structure, finally the cost estimation.

Project: Formula 1 Fast Track

Project Description: Its a team project we had selected the land and construct a track for car race with sports

stadium, stands, and all other requirements for a track.

Panacea Biotech Ltd,

Project: cGMP Compliance on Solid Dosage Forms

Project description: Introduction and ideal requirements for cGMP

Requirements for manufacture of Solid Dosage Form

Practical report of the batch manufacturing of Nimuslide

Review about Production, Quality Control and Quality Assurance department.

Guru Gobind Singh Indraprastha University, India

Project: Deciding on Advertising Budget

Project description: It’s a project to design a realistic advertising budget for a new company by explaining about the

procedures and best methods for creating a realistic advertising budget by different pharmaceutical companies with

companies survey and Surveys in general public for their opinion on pharmaceutical companies advertisements.

Papers and Presentations

New Jersey Institute of Technology, USA

Review Paper and Presentation:

• LC/MS and their application in pharmaceutical industry

• Toxicology of 2,4-D

• Analysis of Hydrogen cyanide in Air

Presentation: Mechanism of Action and Proposed modification to Improve Activity of SULFAMETHOXAZOLE

DRUG

Guru Gobind Singh Indraprastha University, India

Presentation: Implantable therapeutic systems

HPLC and its application

Skills & Achievements

• During my project handling, I have developed an ability to meet realistic targets within tight constrains of

time and resources.

• My proactive and organized approach has enabled me to handle a variety of tasks efficiently in academic

and professionally

• Proficient user of all Windows Applications including Microsoft Office - Word, Excel, Powerpoint, Outlook

& Publisher, Microsoft visio2007, Microsoft project2010.

• Excellent presentation skills developed while presenting scientific data in coursework’s and presentations.

•Strong documentation skills were developed throughout my course.

•Proficient in technical and non-technical communication, both in oral and written

•Good leadership skills and has the ability to guide and provide technical direction and supervision for a given

project

•Excellent problem solving, analytical and logical thinking skills

Awards and Honors

• Honored with first division in Bachelors of pharmacy degree.

• Honored with Registered Pharmacist by Delhi Council of Pharmacy

• Honored with 2008’s best pharma week event organizer.

• Honored with Memento and Appreciation Certificate for Research Coordinator Post

Workshop Attended

• 14th annual conference of Pharmacognosy held at KEL University’s college of Pharmacy Feb2010.

• 7th annual graduate student research day at New jersey institute of technology Nov2011

Activities

• Member of graduate student research day2011 organization committee.

• Member of Masquerade ball night 2012 organization committee.

• Volunteer in 9/11 Unity Walk in NY on 9/9/2012

• Member of Pharma organization committee in GGSIPU, India.

• Member of Red Cross Society, India.

• Volunteer Coordinator in Blood Donation Camp in GGSIPU, India.

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