Project Process
Resume:
Evelyn Velez Zayas
Mansiones en Paseo de Reyes **9H Calle Rey Fernando Juana D az, Puerto Rico
00795
********@*******.***
Summary of Qualifications
Over five years of diverse validation experience in the Pharmaceutical
industry. Enthusiastic, ingenious, and results oriented professional.
Highly effective in teamwork environment. Oriented towards resolution of
problems. Knowledge of principal and supplemental FDA Regulatory
Guidelines like: Solid Dosage Blend Uniformity, Dissolution Guideline,
Stability Guidelines, cGMP, Conformance Standards, SUPAC and SOP's.
Experienced in Project Management, Statistical and Validation Concepts
(Process, Equipment and Cleaning Validations). Exposure to a consent
decree environment, with ability to work under stressful circumstances and
minimum supervision. Team work oriented with proven effective leadership
skills. Working knowledge of MS Word, Excel, Power Point, Microsoft
Project, Visio and Minitab Statistical Software. Bilingual in Spanish and
English.
Accomplishments
. Participated as Core Member for Validation New Era Project.
Recommendations resulted in the implementation of a new validation
methodology, reduced validation time and costs and eventual
implementation at several national and international sites.
. Performed investigation on solid dosage batch to determine the reason
why the product was not meeting established parameters. Findings
resulted in the revision of manufacturing parameters, FDA approval and
significant savings with the final release of the product.
. Designated as Subject Matter Expert (SME) for process validation, in
solid dosage products resulting in 100% compliance with FDA site
requirements.
. Recognized for outstanding performance in several validation
initiatives.
. Created, implemented and successfully managed different projects
meeting established objectives and metrics with outstanding results.
. Acquired working knowledge of FDA and Wyeth guidelines, applied in
process validation projects.
Professional Experience
Pfizer (Previously Wyeth Pharmaceutical), Guayama, Puerto Rico
QA Lead Investigator I
2009 - 2010
. Provided guidance, coaching and coordination for all aspects related
to the initiation, tracking, trending and management of all
manufacturing and/or laboratory investigations (as applicable based on
assigned area), corrective and preventive actions (CAPA), evaluation
of CAPA effectiveness and Operational Excellence projects within the
PPU/FU.
. Worked with the PPU/FU leadership team to facilitate the consistent,
disciplined execution of the MIR/LIR quality system ensuring the
completeness and comprehension of the investigations and determination
of most probable root cause.
. Reviewed and analyzed corrective and preventive actions effectiveness
through appropriate tracking and trending methods in order to prevent
reoccurrence.
. Provided timely coaching and feedback to investigators related to the
completeness and quality of the investigation reports.
. Provided action plans to implement corrective/ preventive actions
and/or improvement projects related to product's quality, compliance
and process robustness.
. Provided Quality Area evaluation of all manufacturing investigations.
Wyeth Pharmaceutical, Guayama, Puerto Rico
Technology Process Specialist IV
2004 - 2009
. Developed and/or executed protocols and reports for Process
Optimization, Equipment Validation, Process Validation and Cleaning
Validation.
. The activities performed on these projects included but not limited to
the following: Project Management, Writing, Training, Execution, Data
Collection and Analysis, Cleaning Certifications, Reporting and
Recommendations.
. Developed Process Statistical Analysis for process control improvement
and optimization.
. Actively participated in Schedule meetings to follow up and plan
execution of corporate projects.
. Generated Change Controls for equipment and processes validations.
. MIR meetings to discussed evaluation plan for various equipment and
processes related to manufacturing discrepancies following CAPAS as a
problem-solving tool.
. Provided Technical Inputs for Manufacturing Discrepancies.
. Participated in Master Batch Record (MBR) review as part of a process
yield improvement project.
. Revised Standard Operating Procedures.
. Provided support to other areas by reviewing report data for process
validations and equipment qualifications.
. Reviewed and Approved MBR.
. Executed procedures following FDA's Guideline on Process Validation
and SUPAC-MR recommendations.
Abbott Laboratories, Barceloneta, Puerto Rico
Student Intern-Pharmacist
2003 - 2003
. Trained in manufacturing process like as: Granulation, Blending,
Compression, Coating, and Printing. Manufacturing Formulas. Package
Master.
. Basic Operation Procedures.
. Visited Laboratories Microbiology and Chemical. Learn from Deviations
Procedures.
. Learn Certification Request (CCR).
Medical Sciences Campus, University of Puerto Rico
Teacher Assistant Laboratories Classes
2002 - 2002
. Assisted in the laboratories preparation of the following dosages form
like as: Suppositories.
. Lotion Calamine.
. Lugol solution and emulsion (w/o) and (o/w).
Education
University of Puerto Rico Medical Sciences Campus, R o Piedras Puerto Rico
Master in Industrial Pharmacy
University of Puerto Rico, Arecibo Puerto Rico
Bachelor in Science in Microbiology (Cum Laude)
Trainings
. Train the trainer
. Problem Solving and Decision Making
. 7 Habits of Highly Effective People by Frankly Covey
. CAPA
Additional Skills
Minitab Statistical Software Certification. Basic Statistical Training -
ASQ. Failure Mode and Effect Analysis (FMEA), Fault Tree Analysis (FTA-
Fishbone /Cause & Effect diagrams). V-Blender, IBC Blender, Roller
Compactor, Barrel Blender, Aeromatic Fluid Bed Dryer, Filter Washer and
Dryer. Manesty Tablet Press, Fette 3090. Accela Cota 60" Coating System,
Spectrum Coater, Procoater, Pellegrini. Microsoft Windows applications.
Microsoft Word. Microsoft Excel. Microsoft PowerPoint. Microsoft Project.
Visio. Minitab Statistical Software. Laboratory Information Management
System (LIMS). SAP. Trackwise. Electronic Document Management System
(EDMS). Internet as a research tool. Compile statistical reports to trend
data, based upon analysis and testing.
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