Associate Director of Validation Consultant - Rockville, United States - The Verity Collective

The Verity Collective
The Verity Collective
Verified Company
Rockville, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Job Overview:


We are seeking a highly skilled Associate Director of Validation (10+ years experience) to join our team as a consultant for a 6-9 month on-site Contract in Rockville, MD.


  • Review and enhance Validation Master Plan to include comprehensive facility and equipment qualification lifecycle.
  • Gap Assessment of Validation Plan for both Facilities and Computer Systems
  • Review and create recommendations regarding completed commissioning of production suites.
  • Review and create recommendations for commissioning work on new facility buildout to include material warehouse.
  • Oversight of CSV activities for Document Control and Training Systems (should be able to provide high level guidance)
  • Train new hires in QE/Validation space
  • Provide guidance on maximizing product capacity and use of GMP suites.
  • Review and enhance CSV program.
  • SOP development
  • Develop and manage inventory of computer systems software.
  • Assessment of all equipment
- identify gaps for early phase to pivotal transition and related requirements for data integrity.


  • Review current risk scenarios and advise on additional risks.
  • Author SOPs and perform validation as needed.

Job Type:
Contract


Pay:
$ $120.00 per hour


Experience:


  • Management: 5 years (required)

Ability to Commute:

  • Rockville, MD (required)

Work Location:
In person
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