Ed Roach

Ed Roach Email and Phone Number

Managing Partner at GxPartners @ GxPartners
indianapolis, indiana, united states
Ed Roach's Location
Panama City, Florida, United States, United States
Ed Roach's Contact Details

Ed Roach work email

Ed Roach personal email

n/a

Ed Roach phone numbers

About Ed Roach

A dedicated results-oriented professional known for highly-developed organizational skills, advance problem resolution, flexibility, and high standards. Experienced consulting program and project manager who has been responsible for selling, staffing, and delivering compliance and quality consulting engagements to FDA regulated clients. Technical skills include extensive experience in Computer System Validation (CSV), Process Validation, and Equipment/Facility/Utility Qualification. Experienced in Validation Master Planning and Validation Program Development with a specialization in risk based approaches to validation projects. Also in depth knowledge of Quality Systems, Quality Assurance, Quality Control, CAPA, Post Market Surveillance, Root Cause Investigations, Change Control, and 483/Warning Letter Remediation.

Ed Roach's Current Company Details
GxPartners

Gxpartners

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Managing Partner at GxPartners
indianapolis, indiana, united states
Website:
gxpartnersgroup.com
Employees:
4
Ed Roach Work Experience Details
  • Gxpartners
    Managing Partner
    Gxpartners Aug 2020 - Present
    United States
    GxPartners mission is to provide risk-based Quality, Validation and Regulatory Compliance staffing and consulting services for the Life Sciences Industry.We have the capacity and flexibility to scale our services to meet our client’s unique needs. GxPartners provide talented individuals to meet your short-term Quality and Regulatory needs, or provide a team of resources to help manage and support larger, multi-site remediation projects in response to an FDA Warning Letter.Our Founding Partners have each been performing quality, regulatory, and validation services in support of Life Sciences clients throughout their careers, and are combining their knowledge to create a company capable of truly supporting the many needs of manufacturers in the Life Sciences Industry – primarily Pharmaceuticals, Medical Devices, and Biologics.
    View
  • Maetrics
    Senior Vice President, Strategic Accounts
    Maetrics Jul 2017 - Aug 2020
    Indianapolis, Indiana Area
    View
  • Maetrics
    Managing Director
    Maetrics Jan 2016 - Jul 2017
    Indianapolis, Indiana Area
    View
  • Barry-Wehmiller Design Group
    Director, Compliance And Validation
    Barry-Wehmiller Design Group Aug 2014 - Dec 2015
    Indianapolis, Indiana Area
    View
  • Maetrics, Llc
    Vice President Of Consulting
    Maetrics, Llc Nov 2011 - Aug 2014
    Indianapolis, Indiana Area
    View
  • Maetrics, Llc
    Director- Compliance, Quality, And Technology
    Maetrics, Llc Sep 2010 - Nov 2011
    Indianapolis, Indiana Area
    View
  • Roche Diagnostics
    Quality Services Validation Principal
    Roche Diagnostics Feb 2008 - Sep 2010
    Indianapolis, Indiana Area
    View
  • Maetrics, Llc
    Operations Manager/Validation Consultant
    Maetrics, Llc 2004 - 2008
    Indianapolis, Indiana Area
    View
  • Avon Products
    Regulatory Compliance Specialist
    Avon Products 2001 - 2004
    Springdale, Ohio
  • Meridian Bioscience Inc.
    Technical Validation Associate Ii
    Meridian Bioscience Inc. 1999 - 2001
    Cincinnati, Ohio
    View
  • Meridian Bioscience Inc.
    Production Scientist
    Meridian Bioscience Inc. 1998 - 1999
    Cincinnati Ohio
    View
  • University Of Cincinnati College Of Medicine
    Research Assistant
    University Of Cincinnati College Of Medicine 1997 - 1998
    Cincinnati, Ohio
    View

Ed Roach Skills

Capa Fda Validation Quality System Iso 13485 Change Control Quality Assurance 21 Cfr Part 11 Gmp Computer System Validation V&v Quality Control Medical Devices Design Control Pharmaceutical Industry Quality Auditing Sop Cross Functional Team Leadership Corrective And Preventive Action U.s. Food And Drug Administration Regulatory Affairs Gxp Process Improvement Iso 14971 Glp Regulatory Submissions Biotechnology Quality Management Gamp Biopharmaceuticals Root Cause Analysis Software Documentation Management Technology Transfer Process Validation Regulatory Requirements Aseptic Processing Iso Process Simulation Standard Operating Procedure Lims Life Sciences Business Process Improvement Iso Standards Cleaning Validation Project Management Fmea Manufacturing

Ed Roach Education Details

Frequently Asked Questions about Ed Roach

What company does Ed Roach work for?

Ed Roach works for Gxpartners

What is Ed Roach's role at the current company?

Ed Roach's current role is Managing Partner at GxPartners.

What is Ed Roach's email address?

Ed Roach's email address is er****@****ics.com

What is Ed Roach's direct phone number?

Ed Roach's direct phone number is +131296*****

What schools did Ed Roach attend?

Ed Roach attended Miami University.

What skills is Ed Roach known for?

Ed Roach has skills like Capa, Fda, Validation, Quality System, Iso 13485, Change Control, Quality Assurance, 21 Cfr Part 11, Gmp, Computer System Validation, V&v, Quality Control.

Who are Ed Roach's colleagues?

Ed Roach's colleagues are Christopher Mcginn, Keisha Keglar.

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