Management Project

Fatima Zaidi, MS, PMP, Lean Six Sigma

*** **** ***** **, *******, GA, Tel. 404-***-****, E-mail:

abmebd@r.postjobfree.com

Summary of Experience

PMI certified Project Management Professional (PMP) and certified Lean Six

Sigma Black Belt. Experience in clinical trial supply management for Phase

1-3 trials in area of CNS and Rheumatology. IVRS/IWRS set-up for complex

trails. Comparator development. Packaging, labeling, distribution and

returns planning. Stability program/bio-equivalence. Medical device

quality system set-up. Audit of drug returns process/gap analysis.

Statistical analysis using Minitab. Strategic planning; balance scorecard,

and dashboard.

Key Skill Areas

Clinical Supply Management Drug Product Label Process Improvement

IVRS/IWRS implementation GMPs/GCPs Project Management

Import/Export requirements Demand Planning Excel/Pivot

Tables/Minitab

Distribution/Logistics Contractor Management Scorecard/Dashboard

Planning

Professional Experience

UCB, Inc. Clinical Supply Manager (Coordinator)

2006 - 2009

Pharmaceutical company with two blockbuster drug on the market, Keppra

and Zyrtec. Worked in product development as member of clinical

supply planning group, responsibilities included:

. Managed multiple clinical trial supply trials, created project

deliverables, packaging designs, product labels, project plans,

tracked project timeline and budget. Provided updates to senior

management.

. Coordinated work with packaging, labeling, comparator development, and

IVR vendors based globally. Successfully negotiated issues, finding

solutions, building consensus to achieve timely completion of

projects.

. Implemented complex IVR/IWR system for Ph III flexible dose program.

Involved in RFP review, vendor selection, developing system

requirements, user acceptance testing, and system launch.

. Utilized IVR/IWR to full potential; randomization, inventory

management, expiry date management, drug lot traceability, and drug

return handling.

. Forecasting, performed short and long term demand planning across all

projects, created global distribution plans. Knowledge of

import/export requirements.

. Resolved quality issues with vendors, prepared investigation reports,

performed root cause analysis. Liaised with regulatory group

Key Accomplishments:

. Achieved cost savings of ~ $100,000.00 by careful set-up IVRS supply

trigger levels, created balance between no. of shipments, and on-site

inventory.

. Met key performing indicator (KPI) by 100% for on time drug delivery

across all projects.

. Successfully handled comparator development for a Ph. I abuse

potential trial, with triple dummy study design. Despite considerable

scope changes, managed project completion on time, critical to IND

submission.

. Identified/Improved operational issues with suppliers. Saved over

$250,000.00 in over invoicing. Escalated issue to upper management.

Facilitated meetings to resolve issue.

. Won approval from multiple layers of management for implementing IVRS

system for Ph. III study mid project. Prepared cost benefit analysis

and action plan.

. Achieved on time start for Ph. III clinical trial with aggressively

reduced timeline. Performed fast tracking, and utilized synergies to

achieve the target timeline.

Lean Six Sigma Black Belt Project (2009-2010)

. Reduced packaging defects using Lean/ DAMIC tools: voice of

customer/business, SIPOC, Ishikawa diagram, SPC charts, FMEA analysis,

value stream and process maps, Kaizen event, hypothesis testing.

. Developed strategic plan for vendor performance management: balanced

scorecard with key metrics, and interactive performance management

dashboard.

. Statistical analysis using Minitab: analysis of variance (ANOVA),

histogram, statistical process control (SPC) charts.

ALTEA THERAPEUTICS, Quality Assurance Associate

2004 - 2006

Medical device company developing trans-dermal device and patch for drug

delivery. Member of Quality Assurance group, responsibilities were:

. Clinical inventory management, auditing, and returns handling.

. Created approved vendor database for medical device. Improved

material traceability system

. Set up quality system in compliance with good manufacturing practices

(GMPs) and FDA guidelines from 21 CFR Pt. 210/211,820.

. Created standard operating procedures, change control documents.

Reviewed batch records, and drug product labels.

. Conducted internal audit and gap analysis to improve compliance with

existing SOPs. Conducted equipment, process, and documentation, and

lab notebook audits.

Key Accomplishments:

. Optimized processes by performing internal audits and gap analysis.

Gor rid of non-value added steps/documentation.

. Reduced process time for CAPA, and change control completion by

working with area management and employees across the company.

PARSONS ENGINEERING SCIENCE, Senior Scientist 1998

- 2001

Global environmental and engineering consulting firm. Part of Regulatory

Affairs group, working on multiple projects with clients, responsibilities

were:

. Performed lab data validation. Liaised with contract labs, resolved

quality issues.

. Prepared project specific sampling and analysis plans, and

qualification packages.

. Worked on multi-functional project teams, performed project management

for specific tasks, monitored task specific budget, timelines, and

contract labs.

Key Accomplishments:

. Resolved environmental compliance issue(s) proving that client was not

responsible for current environmental problems.

. Created smooth flow of information by standardizing

procedure/documentation across numerous counties

HnH Trading Inc., Owner Operator

2001-2004

Started home based business selling electronics. Helped take business from

start-up to sales of $ 0.5 million in 3 years: revenue cycle management

GA ENVIRONEMNTAL PROTECTION DIVISION, Lab Scientist

1997-1998

Drinking water analysis, GC-MS, GC-ECD, UV-Vis Spectroscopy.

Education and Certifications

Master of Science, Environmental Chemistry, Aug 95

University of Albany, NY, USA

Certification: - Project Management Professional (PMP). Project

Management Institute, USA. Jan 2009

- Certified Lean Six Sigma Black Belt. Georgia

State University, USA. Jun 2010

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