Quality Assurance Training

UZMA V. KADRI

**** ******** **.***** ****, TX ***79

*.*****@**********-**********.***

******@*****.***

Tel: 908-***-**** cell, 908-***-****

CREDENTIALS

Ten years work experience in Global Quality and Global Supply Chain functions at large Biotechnology and Pharmaceutical corporations. Five years of hands-on consent decree work plan remediation team projects experience.

Trained in enterprise quality systems (TrackWise, ISoTrain, JD Edwards One World, Plateau, Documentum, Livelink, and SAP-MM)

Performing functional SME roles in the following topics (GMP training, non-conformance and investigations, and product complaints handling, Adverse Event Reporting)

Completed the ASQ-Certified Quality Auditor course in November, 2005

Key Strengths: Detail oriented in problem solving and facilitating issue resolutions across cross-functional teams. People oriented with strong relationship and team management skills.

PROFESSIONAL EXPERIENCE

Hospira, Rocky Mount, North Carolina 7/2013 to current

Quality Reviewer / Investigations Consultant, On Contract – Oxford Global

Conduct QA Review of Biological Quality EQA laboratory CLIMET Logbooks in response to a FDA commitment. Review logbooks for NVP, particulate data, alerts and alarms and corrective actions for cGMP-controlled areas. Provide support to Analytical Laboratory investigations specifically OOS (Out of Specification) Investigations.

Sanofi-Pasteur, Toronto, Canada 1/2013 to 3/2013

Managing Consultant, On Contract - Tunnell Consulting, Inc.

Conduct Training teams in transforming the training capability across the Toronto site in response to completing the FDA Commitment response. Provide subject matter expertise to departments in Industrial Operations, Quality Assurance, and Quality Control with respect to completing the new lesson plans on the FDA approved lesson plan template.

Genzyme, A Sanofi Company, Boston, MA 12/2011 to 06/2012

Senior Compliance Specialist, On contract - PRO Unlimited, Inc.

Support the protocol execution by conducting investigations on the backlog of deviations in Quality and Operations, in response to the commitment made to a 2011 FDA observation.

Conduct major and minor investigations in Cell Culture Upstream manufacturing, on outstanding deviations related to Manufacturing Batch Records, QC test results, Out of Specification results for release of Fabrazyme, Cerezyme batches / product to market.

Prepare investigation reports and propose CAPA strategies to eliminate root causes of deviations.

Work with Manufacturing, QC labs and Quality Assurance management to gain third party (Quantic) certification on completed investigations.

Review and interpret various batch, production, quality control testing, and training records to ensure compliance with Genzyme Quality Standards and FDA cGMP guidelines.

Regulatory Excellence Partners, Sugar Land, TX 01/2009 – 12/2011

QA, Training, and GMP Documentation Consultant

Client Projects:

Conduct an enterprise-wide compliance audit of two quality systems – Non-conformance/ deviations and Investigations, and Change Control Management.

Support a client with QA reviews, processing, and closure of open non-conformances, completing investigations and verify closure of related CAPAs in Track Wise QIMS.

Perform GMP Training manager responsibilities involving review and processing of position-specific training curriculums, course modules, and learning plans. Develop departmental SOPs. Deliver trainings in a Train-The-Trainer format.

Support a client with QA release and review of master batch records comprising of central weigh records, manufacturing batch records (MBR), master packaging records (MPR)

Conduct document reviews against checklists for meeting GDP and GMP compliance requirements. Perform documentation specialist responsibilities involving formatting, approval and change control of SOP(s) in compliance with quality system requirements.

Assist / deliver GMP Training workshop(s) with Skills Assessment while servicing a contract between RE Partners and the New Jersey Biotechnology Fund, State of NJ and MedImmune Biopharmaceutical.

Support a client in reviewing, processing, and tracking of product complaints for investigational and marketed products. Review Drug Safety SOPs and review, process Adverse Event reports to maintain internal and agency reporting timelines.

Merck Schering-Plough Corporation. Kenilworth, NJ 2003 - 2008

Corporate Law Office, Global Functions 10/06 – 11/08

Responsible for contract, litigation and trademark file room processes and creating/managing daily work schedules for contract employees.

Support the law office SOP upgrades to comply with legal requirements for contracts, patents, and secrecy agreements into TeamConnect & Matter Management. Maintain quality assurance and compliance requirements by training contract employees.

Support retrieval, archiving and filing of records submitted by company lawyers into the records management systems. Use Contract Management System (CMS), iManage, TeamConnect, and e-file management systems. Conduct quality assurance checks, audits and document review of records entered into systems.

Assist law office attorneys with searches/retrievals of contracts, patents, agreements, & other research. Manage subscriptions, invoicing, circulation, and renewals for a variety of publications, manuals, Journals, Lexis/Nexis, Westlaw CourtLink and other search engines.

Sr. Purchasing Coordinator, Global Strategic Sourcing 07/06 - 10/06

Senior Purchasing Coordinator’s responsibilities include pre-order verification, order authorization, entry, management, and archival processes.

Act as the primary interface between respective business units and the procurement department. Material orders planning vs. bill of materials, checklists and batch records.

Maintain records of current contracts between GSS and suppliers/vendors, and direct the flow and routing of P.O. processes to buyers, purchasing specialists and order entry staff.

Interact with corporate auditing teams in servicing purchasing document requests.

Use IBM Reflections (and Ariba Procure-To-Pay (PTP) purchasing ordering systems.

Global API Sourcing Specialist (Contract) 10/05 to 07/06

API materials planning in JD Edwards One World system for Schering Plough sites, specifically Singapore and Ireland locations.

Perform materials requirement planning by entering manufacturing and sales orders for product/ inventory planning and ordering activities.

Create manufacturing, QC and sales orders for APIs by alpha codes and grades in JD Edwards. Perform inventory adjustments, product-planning decisions for investigational and marketed products.

GMP Training Specialist [ISOtrain System Administrator] 07/03 to 12/04

Administration of the ISOtrain GMP training system and Trackwise for the Global Supply Chain and Global Quality Operations to fully comply with regulatory/consent decree commitments.

Perform ISO train data systems activities in accordance with ISOtrain change management SOP(s). Direct dealing with customers at all management levels from VP/s, directors, managers to supervisors.

Collaborate with Global IT in developing the migration processes for configuration and transfer of data from GEDMS legacy system into ISOtrain using MS excel and Citrix interface.

Creating & modifying training curriculums and modules by job functions into ISOtrain system.

Conduct Quality Assurance reviews and audit of data collection, entry, and verification functions.

Conduct QA reviews on Change Control requests and follow up on their tasks and approvals to ensure Change implementation and closure.

Generated reports on missing requirements, delinquencies, training history, personal skills inventory, and department curriculums etc. Interact with training liaisons in all departments across Global Quality Operations.

Train employees on SOP/s in functional areas and provide support for new Track wise users.

Harris County, Houston, TX 2002

Principal Interpreter

• Worked as a Principal Interpreter in the HC Criminal Court in open court proceedings.

Language USA, INC 2002

Interpreter

• Provided interpretative consulting services in various state organizations.

New Southwest Montessori, Houston, TX 1997 – 2001

Office Manager

• Developed & managed student curriculum changes. Maintained Student Records.

• Teaching Grade 1 the Montessori curriculum with given lesson plans.

Grammar Middle School, Lahore 1991 – 1996

Middle School Coordinator

• Teaching Ancient History & Physical & Regional Geography to grade 6 & 7.

• Home-room teacher for grade 6 & 9.

• Coordinator for the middle school: Duties; responsible for curriculum development, arranging & participating in quarterly PTAs..

• Manage student data and perform periodic audits of student files and records.

EDUCATION & TRAINING

Bachelor of Science / Arts, Major - Psychology & Philosophy, Kinnaird College for Women

ASQ - Certified Quality Auditor Training, Course completed in November 2005.

COMPUTER SKILLS

TrackWise QIMS System, ISOTrain Training Management System, JD Edwards One World, SAP Material Management, IBM Reflections, AMAPS with Citrix MetaFrame. MS Office (Outlook, Word, Visio, Excel & PowerPoint)

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