abn427@r.postjobfree.com

Objective Seeking a challenging and rewarding position in the field of Information Technology (IT) that will use my Quality

Assurance (QA) experience in pharmaceutical industry, and enable me to make a positive contribution.

Strengths Strong QA experience in Pharmaceutical industry as a Quality Assurance Lead for Manufacturing. I am

conversant with quality processes, regulatory and compliance directives and interfaced with IT Leads to ensure

Reshma

Nadgauda – QA

Tester

1476 Windmill Way,

Simi Valley, CA 93065

805-***-****

business needs are met. Now I want to leverage that experience in IT Testing, as a Tester and set-up/enhance

processes for testing of applications.

Training July 2012 - Present QA training in the field of IT

Topics covered in the training:

• Study of the Business Requirements and Understanding the Business Functionality of the Application

Under Test (AUT)

• Design the Functional Test Cases for the Application under Test

• Maintaining the Traceability between the business requirement and the Test Cases, Execution of the

Test Cases and Verification of the Execution Results

• Defect Reporting and Logging these defects in Quality Center

• Co-ordination between Offshore and Onsite Testing Teams and conduct defect status meetings.

• Designing Functional Automation scripts of the designed test cases using Win Runner, Load Runner,

QTP (Quick Test Professional), and Selenium

• Execution of the Automation Scripts

• Maintaining Automation Traceability Matrix between the automation scripts and the test cases

• Experience in testing web applications, stand-alone and Client/Server applications using Functional,

Black Box, Integration, System, Load, Security testing, End-to-End testing, Smoke testing,

Performance testing, Web testing, Stress testing, User Acceptance Testing, Boundary testing and O/S

compatibility testing

Systems and Applications used:

• JD Edwards for (ERP) Materials Management and Lot release

• Oracle SQL LIMS (Laboratory Information Management Software) for Lab tests and results

• Cerity ECM from Agilent technologies for data management (storing excel, pdf and word files

• Trackwise EQMS (Enterprise Quality Management Systems) for non-conformances and QTS (Quality

Tracking Systems) Trackwise for Supplier Quality

• SAP crystal reports for designing /extracting data from various applications like JD Edwards and LIMS

to generate reports

• OSI PI systems to store the real time data and events so manufacturing reports and trends can be

generated. It is a historian to store all manufacturing processes. Citirx sever is used to review the

manufacturing processes later by QA

• Product lifecycle management (PLM) to review and approve workflows for SOPs, Manuals and

Change Requests for Change Control

Testing Tools: Quick Test Pro, Quality Center, Win Runner, Load Runner, Selenium

Experience February 2002 - October 2012 Baxter Bioscience Thousand Oaks, CA

Full Time Employee - Quality Associate II

• Working in Quality Assurance for Review of Formulation and Finishing Runsheets, QC lot results ensuring

all documentation is in Compliance to cGMPs (current Good Manufacturing Practices), GLPs (current

Good Laboratory Practices), and SOPs (Standard Operating Procedures). Ensure all steps are

documented; processes performed are within limits, all required testing has been performed and

specification/product license requirements have been met, all non-conformance reports are closed before

approving and executing release of Final Container Product ensuring the quality, safety and efficacy, with

knowledge of cGMP (US, EU, Canada, Japan)

• Responsible to ensure correct product status in JD Edwards (ERP) database (e.g. Quarantine, Hold,

Released, Reject etc.)

• Review QC testing and disposition lots in LIMS (Laboratory Information Management System)

• Interacting with all levels of Manufacturing, QC, QA, Planning and Regulatory Affairs to ensure timely

Release of Product ensuring QA Compliance.

• Lead Investigator for review and approve non-conformance reports within respective areas and write

investigations pertaining to product complaints.

• Facility Labeling Lead to manage Labeling and Artwork changes for Final Container

• Interface with inspectors during FDA (Food and Drug Administration), Corporate and Internal Audits.

• Complete responses and closure of commitments for Audits.

• Prepare Annual Product Review (APR)

• Involved in Quality Systems through Change Control, Document Control, Non Conformance Management,

Supplier Quality etc.

• Understanding of Aseptic Manufacture process.

• Maintain database for individual lots, update monthly release metrics and present agendas in weekly

planning meetings.

• Review data for/by regulatory submissions.

• Write and revise SOP’s in order to be compliant with cGMP’s/Product License requirements.

• Preparing/Reviewing the Test Certifications and Protocols that summarizes the results of the Final

Container Product

• Qualified Trainer to train new employees

• Computer skills for Microsoft Office – Excel, Word, PowerPoint, Outlook, Access and Visio.

• Completed Project Management Methodology training

• Certified Lean Instructor

February 2001 – February 2002 Baxter Bioscience Thousand Oaks, CA

Full Time Employee - Quality Associate I

• Working in Bulk Drug Substance (BDS) Release to ensure all Manufacturing Formula Record (MFR’s)

steps are documented, processes performed are within limits, all required testing has been performed and

meets specification, all non-conformance reports are closed before approving and executing release of

BDS. Preparing and Reviewing the Test Certifications and Protocols that summarizes the results of the

Final Product for submission to different Geographies.

1989–2000 Bureau of Indian Standards Mumbai (Bombay), India

Full Time Employee - Chemist

Bureau of Indian Standards is an organization in India that formulates the standards for testing various food items,

drugs, chemicals etc. and also conducts the testing of above items. These standards are used in Indian Industry similar to

ASTM Standards in USA.

I was involved in "Chemical Testing" of various products like Steel, Pesticides, and Cement etc. as per BIS Standards.

Various instruments I have used include pH meter, UV spectrophotometer, High Performance Liquid Chromatograph

(HPLC), Gas Chromatograph, Carbon Sulphur Detector, Memotitrator, Atomic Absorption Spectrophotometer etc.

I was carrying out “Microbiological Testing" as well as “Generating Test reports “of various food & Drug products as

per BIS standards.

In additional duty as Lab-Administrator I was responsible for managing inventory of various chemicals &

consumables required for Chemical Laboratory that gave me good exposure to using MS Excel & MS Word

effectively apart from getting familiar with Inventory control techniques

Education BS in Chemistry

Mumbai (Bombay) University Mumbai, India

Bachelor of Science (specialization: Chemistry)

National Dairy Development Board Gujarat, India

Microbiological Testing.

References

Furnished upon request

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