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QUALITY ASSURANCE AUDITOR for CSV DOCUMENTATION
Ref No.: 17-00763
Location: Edison, New Jersey
Position Type:Contract
Start Date: 05/22/2017
QUALITY ASSURANCE AUDITOR FOR CSV DOCUMENTATION
EDISON, NJ

Project Description:

  • Reviewing and Auditing GxP CSV documentation and processes. This will be on an "as needed” basis.

Required Skills:

The QA Auditor for Computer Systems Validation Documentation should have the following:
  • Bachelor's degree in physical, life, or computer sciences or a related field.
  • 5+ years of related pharmaceutical experience in computer systems validation/ SDLC.
  • Experience with Quality processes (GxPs) and regulations (e.g., cGMP, GCP, and GLP regulations).
  • The application of cGMP, cGCP, 21CFR Part 11, and other regulatory requirements (e.g. General Principles of Software Validation) and industry best practices (e.g. GAMP) relating to GxP CSV/SDLC activities.
  • Experience in reviewing / auditing GxP CSV documentation and processes.
  • Familiarity with various SDLC methodologies and practices.
  • Experience in performing various types of audits with varying vendors.
  • Familiarity with FDA and other regulatory agencies.
  • Certification (e.g. CQA) from industry recognized societies (e.g., ASQ) is desirable.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #17-00763
W2 ONLY