2004 -2006 Third Party Senior Quality and Regulatory Consultant @ Cordis LLC, San German, PR – ReComs
2002 -2006 Third party - RA and QA advisor @
Barbara Perez Education
Universidad Interamericana
Bachelor Of Science (Chemistry)
1990-1993
Universidad Interamericana
Bachelor Of Arts
1993
University of Puerto Rico
(Chemical Engineering)
1986-1989
Barbara Perez Skills
Validation
Quality Auditing
Quality System
GMP
CAPA
Quality Assurance
Regulations
Compliance
Project Coordination
Project Management
Quality Control
Testing
Process Improvement
Software Documentation
Medical Devices
Change Control
Regulatory Requirements
Sop
Root Cause Analysis
Biotechnology
Manufacturing
Computer System Validation
V&V
FDA
21 CFR Part 11
POE
Pharmaceutical Industry
ISO 13485
Regulatory Affairs
Writing
Certify
Quality Management
Consulting
Suppliers
Chemical
Technical Reviews
Corrective Actions
Master Plan
Validation Engineering
Shipping
Chemistry
Technical Assistance
System Applications
Acting
Manages
Astra
Translation
Procedural
Mentoring
Academies
Finance
Trackwise
Agile Methodologies
Product Complaints
SPR
SAN
Implementation Plans
Utilities
Artwork
NDA
Construction
Groupwise
Dispositions
Deviations
SME
Design of Experiments
Complaints
Law Enforcement
Business Requirements
Third Party
Wow
Assessment
Regulatory Compliance
Concur
Decomposition
Closure
Procurement
CMC
Regulatory Agencies
Categorization
Management
CQE
Design
Public Relations
Impact Assessment
German
Security
Technical Operations
Viewer
Time To Market
Data Backup
Metrics
CQA
Electronic Submissions
Pmb
Auditing
Data Storage
Spanish
Aid
GAP
PowerPoint
Monitors
Lean Manufacturing
Labels
Collaborative
Execution
Equipment Qualification
Qualification
Supplier Evaluation
Purchase Orders
Guidance
Dcr
Entry
Build Relationships
System
Preventive Actions
English
Project Leadership
Occupational Health
Publishing
PDM
Healthcare Compliance
Engineering
Reports
Combination Products
Strategy
New Process
Agreement
Inventory
Medical Device Directive
Declarations
Strategies
Microsoft Office
Revision
Related Activities
Medicine
Contamination
Microsoft Excel
Product Reviews
ASQ
Training
Puerto Rico
Trending
Technical Reports
Materials Management
Operational Excellence
Documentation
Product Development
Research
Informatics
PMP
Commercial Real Estate
Investigation
Livelink
Strategic Vision
Inspection
Revise
Consumables
ROOT
Laboratory
Sterilization
EPC
Comparative Analysis
Equip
SAP
International Regulations
Computer Related
Yahoo
C
Product Testing
Cutters
FIX Protocol
Opus
Complaint Management
Logistics
Cognos
Mechanical
Schedules
Edition
Package Inserts
Detail
Negotiation
GDP
Dossiers
GPC
Advertising
Safety
Container
Operations
Workshops
MatrixOne
Analytical Chemistry
Academia
Statutes
Marketing
Document Management
CMS
Project Implementation
Technical Support
Project Planning
Documentum
Project
Distribution Center Operations
Measurements
Supports
Facilities Management
Writes
RoHS
Endoscopy
Procedures Development
Batch Records
Rabqsa
Responsibility
Internal Audit
Six Sigma
Project Teams
Packaging
Policies and Procedures
Labelling
Distribution
Business Units
Google Groups
Administrative Work
Multi Tasking
Class Ii
History
Start Ups
Forms
Commissioning
Reviews
HVAC
Electronics
Fluids
Checklists
Affiliates
Mastery
Materials
Software
Mpr
Windows CE
Technical Writing
SAS
Consolidate
Global Marketing
Outlook
JD Edwards
Oracle
Product Lifecycle Management
PMI
P&ID
IEC 60601
Microsoft Word
Work Instructions
Compress
Pharmaceutics
Internal Controls
Biologics
Electrical Equipment
Budgets
Quality Improvement
Staff Development
Risk
Arthroscopy
Summit
Delivery
Nitrogen
Evaluation
Coordinate
Process Optimization
Barbara Perez Summary
Barbara Perez, based in Clearwater, FL, US, is currently a Regulatory Affairs Manager at Oscor Inc.. Barbara Perez brings experience from previous roles at Oscor Inc., Johnson & Johnson, Amgen (BES Consulting) and Zimmer Biomet. Barbara Perez holds a 1990 - 1993 Bachelor Of Science in Chemistry @ Universidad Interamericana. With a robust skill set that includes Validation, Quality Auditing, Quality System, GMP, CAPA and more. Barbara Perez has 1 emails and 2 mobile phone numbers on RocketReach.
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