Ursula Wilson is a skilled professional, who works in The Ritedose Corporation, (Trc) main office of which is in 245. on the position of Regulatory Affairs Manager from 2016. This person gained professional experience in more than nine positions at various companies. Ursula Wilson went to the Duke University and got education there from 1988 to 1992. Irmo, South Carolina is the area, where this professional was lastly known to be located. Ursula Wilson's email address and phone can be easily accessed through SoftwareOfficial on demand.
Name variants:
Ursa Wilson,
Ursie Wilson,
Sulie Wilson,
Ursl Wilson,
Ursy Wilson,
Uschi Wilson
Last updated Jun 23, 2024
Contact Information
Last Update
Jul 14, 2022
Email
u_**@bellsouth.net
Location
Irmo, SC
Company
The Ritedose Corporation, (Trc)
Workplace
Regulatory Affairs Manager
Work History
Regulatory Affairs Manager
1 Technology Cir, Columbia, SC 29203
Preparation of Chemistry, Manufacturing and Controls (CMC) regulatory documentation to support generic drug applications in a Contract Manufacturing Organization (CMO). Provide regulatory in...
from Sep 2016
Validation Engineering Manager
1 Technology Cir, Columbia, SC 29203
Responsible for validation of all equipment, processes and utilities in an aseptic Blow-Fill-Seal (BFS) manufacturing facility. Executed qualifications to evaluate process control, equipment...
Dec 2012 — Sep 2016
Validation Engineer
Led validation activities in an oral solid dosage tablet and capsule manufacturing facility. Ensured compliance with federal regulations, cGMP, Good Engineering Practices (GEP) and corporate...
Jan 2009 — Dec 2012
Qa Analyst Consultant
7891 Broad River Rd, Irmo, SC 29063
Documented business processes and workflows for system upgrade gap analyses and design specifications. Generated system use-cases and acceptance testing for verification and validation of sy...
Jan 2008 — Dec 2008
Qa Analyst Consultant
400 Perimeter Center Ter SUITE 300, Atlanta, GA 30346
Gathered requirements from business process owners, customers, development teams and project management. Generated requirement specifications, functional specifications and design documentat...
Apr 2007 — Dec 2007
Quality Assurance and Regulatory Affairs Manager
System and software validaiton for a wireless ambulatory ECG monitoring medical device.
URS, DQ, FAT, SAT, Commissioning, IQ, OQ, and PQ
Wrote 510(k) and interfaced directly with FDA to s...
Sep 2002 — Aug 2006
Computer System Validation Specialist
Performed computerized system validation (CSV) consulting services for client pharmaceutical companies nationwide. Organized system requirements and provided turn-key validation services inc...
Mar 1998 — Sep 2002
Process Engineer, Qa Specialist, Production Supervisor
Illinois
Validation test plan development and execution in parenteral solution vial/ampule manufacturing and packaging. Automated batch record development and validation.
1994 — 1997
Production Supervisor
5452 Betsy Ross Dr, Santa Clara, CA 95054
Supervision of three production lines in interventional cardiology catheter manufacturing.
Jun 1992 — Dec 1993
Education
1988 — 1992
Occupations
Executive
Manager
Marketing Director
Engineer
Engineering Manager
Technology Manager
Sales Specialist
Equipment Tools Purchasing Agent
Operations Manager
Chief Executive
Technical Managers
Department Store Salesperson
Retail Salesperson
Skills
Validation
Fda
Quality Assurance
Gmp
Capa
Computer System Validation
V&V
Testing
Software Documentation
Manufacturing
Medical Devices
Regulatory Affairs
21 Cfr Part 11
Quality System
Pharmaceutical Industry
Automation
Pharmaceutical Manufacturing
Process Redesign
Requirements Analysis
Regulatory Submissions
Cmc Regulatory Affairs
Abbreviated New Drug Application
Standard Operating Procedure
Cmc
Annual Reports
Licensing
State Compliance
Electronic Common Technical Document
Regulatory Documentation
Regulatory Requirements
Written Communication
Microsoft Office
Common Technical Document
Drug Development
Regulatory Filings
Regulatory Intelligence
Generic Drugs
Regulatory Reporting
Regulatory Compliance
Organization Skills
Interpersonal Skills
Ectd
Microsoft Applications
Adobe Professional