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Validation Consultant

Validation Consultant

Job Title: Validation Consultant
Contract Type: Contract
Location: Scotland, Scotland
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: VC021_1504253686
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: September 01, 2017 09:14

Job Description

They need a consultant that has GxP system compliance experience, an SDLC background, familiarity with software development and especially familiarity with agile software development.

Person Specification

  1. Strong background / experience in Quality oversight of core Pharma GxP Systems (laboratory, manufacturing, packaging, labeling) development and validation
  2. Strong background / experience in writing GxP CSV documentation - although this role will not be writing much of any CSV documentation, it is hard to provide oversight over something you have not done yourself
  3. Strong knowledge of applicable regulatory and industry regulations and guidance (FDA CFR Parts 11 and 211, MHRA Volume 4 Annex 11 and 15, GAMP 5)
  4. Knowledge of current Data Integrity guidance (MHRA, FDA) is a strong plus
  5. Experience in Agile software development processes is a plus, but not as important as applicable GxP systems experience, Quality oversight experience and regulatory/industry experience
  6. Experience in actual software development (design, coding, testing) is a plus, but is not a necessity

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