Dagmar Bon has been a Validation Project Manager at Raland Compliance Partners, Llc since 2016. Additionally, the professional has professional experience at more than 17 companies in the related field. Dagmar has a total work experience of 23+ years. Dagmar Bon studied at the Colorado Technical University from 2012 to 2016. Dagmar Bon learned Spanish, English, Italian, and Portuguese. This person has the following certificates: Pmp, Total Quality Management, Root Cause Analysis Certification, Six Sigma Certification, and License 2780844. Now the professional lives in San Francisco, California region. Find Dagmar Bon's actual email address and number with Connexy search.
Name variants:
Dagmar Bon
Contact Information
Last Update
Jul 13, 2022
Email
da**@yahoo.com
Location
San Francisco, CA
Company
Workplace
Validation Project Manager
Fairport, NY
Industry
Pharmaceuticals, Operates A Medical Laboratory Specializing In Testing
Colleagues
Work History
Validation Project Manager
1250 Grove Ave SUITE 200, Barrington, IL 60010
Technology transfer from US to Mexico, equipment, process validation, ISO and FDA readiness. Lead a validation team of local employees. The plant is an electromechanical box-build and PCBA m...
from Sep 2016
Principal Quality Validation and Pm International Consultant
SME in Quality, Compliance, Data Integrity, Batch Record Review, Auditing, FDA Remediation, Various Quality Systems Investigations and Non-conformances (CAPAs, Deviations, OOS), Validation (...
Nov 2015 — Jun 2016
Quality-Brr
4815 Emperor Blvd SUITE 300, Durham, NC 27703
Perform audit and review of already completed batch records and associated data as well as significant deviations associated with each batch. Develop and submit a summary of findings with re...
Nov 2015 — May 2016
Expert Council Member, Glg Research
60 east 42Nd St, New York, NY 10165
Providing expert-level advice to medical device, biotech and pharma leadership, institutional investors, private entities and professional services firms on development strategies, meeting t...
from Apr 2016
Pm Quality Engineer Consultant
6201 South Fwy, Fort Worth, TX 76104
Execute thermal validation projects for SIPs/CIPs, Reactors, Gamma Sterilization, Filtration and Eto. Prepare validation plans for process, equipment and facilities. Conducted validation pro...
Mar 2015 — Oct 2015
Principal Cvs and Quality and Pm
333 Lakeside Dr, Foster City, CA 94404
Wrote validation documentation for plant control systems (LabWatch, Trackwise and PCS Factory Talk). Documentation was for new API pilot plant VP, URS, FS, DS, Trace Matrix, Risk Assessment,...
Oct 2014 — Mar 2015
Senior Quality Engineer
11606 City Hall Promenade SUITE 204, Fort Lauderdale, FL
Assisting the Quality Department issue, complete and resolve their Non-Conformances for the PSP (Patient Specific Product) Division. Writing protocols providing technical support to manufact...
Feb 2014 — Oct 2014
Senior Capa Engineer
920 Winter St, Waltham, MA 02451
Responsible for the timely initiation, investigation, implementation, and monitoring of assigned CAPA/NC projects, partnered with Quality Systems personnel and responsible to drive continuou...
Oct 2013 — Feb 2014
Senior Quality Validation Engineer-Reglera
300 east Lombard St SUITE 1510, Baltimore, MD 21202
Wrote and executed protocols (IQ, OQ, PQ), and proving technical support to manufacturing, process validation and R&D, CAPA process.
Apr 2013 — Jul 2013
Senior Supplier Quality Consultant-Reglera
345 east Main St #p/o box 708, Warsaw, IN 46580
Updated Zimmer’s FURLS (FDA Unified Registration and Listing System) for vendors to be in compliance as required by 21 CFR 820.198 and a corporate CAPA.
Feb 2013 — May 2013
Senior Validation Engineer Consultant-Reglera
100 Boston Scientific Way, Marlborough, MA 01752
Writing and executing protocols for their manufacturing facility. IQ, OQ, PQ, PPQ, aTMV, vTMV, pFMEA, Packaging Validation, Test Method Validation, CAPAs, Gap analysis, Risk Assessments, Rem...
2005 — Mar 2013
Senior Validation Engineer and Pm
190 north Milwaukee St, Milwaukee, WI 53202
Writing and executing protocols (IQ, OQ, PQ), and proving technical support to manufacturing, process validation and R&D, CAPA process.
2005 — 2013
Senior Validation Engineer Consultant
2825 Airview Blvd, Kalamazoo, MI 49002
Writing procedures for Facilities, EHS, Security, Calibration and Supplier Quality Departments, Validation Plans, Divisional SOPs, WIs, Life Cycle process development and Software Validation...
Jul 2011 — Sep 2012
Senior Validation Consultant
Validated the Rockwell-Allen Bradley controls for the CIP system for the manufacturing facility. Conducted Cleaning Development Studies, and validated 4 Reliance 680 Bottle Washers. Cycle De...
Dec 2004 — May 2005
Owner-Principal Consultant-Managing Partner
Assisting various companies in all aspects of 21 CFR Parts 11, 210/211/600/820 while specializing in the following QMS elements: Operational Support, Regulatory Compliance, CAPAs, Delta V SME
from Jan 2001
Principal Quality Engineer
Responsible for the timely initiation, investigation, implementation, and monitoring of assigned CAPA/NC projects, partnered with Quality Systems personnel and responsible to drive continuou...
from Jan 2001
Education
2012 — 2016
1986 — 1992
Occupations
Executive
Partner
Project Manager
Sales Specialist
Equipment Tools Purchasing Agent
Scientist
Biotechnology Professional
Professor
School Principal
Counselor
Subject Matter Expert
Chief Executive
Project Managers
Department Store Salesperson
Retail Salesperson
Biologist
Biological Scientist
School Administrator
Educational Manager
Advisor
Skilled Professional
Skills
Validation
Fda
Iso 13485
Quality System
V&V
Medical Devices
Gmp
21 Cfr Part 11
Capa
Quality Assurance
Computer System Validation
Testing
Process Simulation
Glp
Software Documentation
Corrective and Preventive Action
Biotechnology
U.s. Food and Drug Administration
Design of Experiments
Sop
Manufacturing
Design Control
Verification and Validation
R&D
Cross Functional Team Leadership
Standard Operating Procedure
Research and Development
Gxp
Good Laboratory Practice
Laboratory Information Management System