1 year contract
*West Point PA, PA *

   - A minimum Bachelor's degree in a science or technology discipline
   - 8+ years of industry experience including computer system validation,
   SDLC, Validation, and/or QA experience.
   - Experience working in a Pharmaceutical environment in a regulated
   (GxP) environment
   - High level of expertise in computer system validation regulations
   including 21 CFR Part 11, Part 58, Part 210, Part 211 and Part 820 is
   required. Knowledge of the EU Annex 11 regulations is preferred.
   - High level of expertise in SDLC methodology (e.g., waterfall, agile,
   spiral) including change management
   - Excellent written and communication skills including thorough
   knowledge of Good Documentation Practices
   - High level of experience in managing and conducting change control,
   validation planning and summarization
   - High level of experience writing Quality Assurance or Validation Plans
   and Summaries as well as change plans and change summaries
   - High level of experience providing guidance for adherence to SDLC and
   corporate and regulatory procedures.
   - High level of experience in ITIL change management and SOPs supporting
   this process
   - Previous experience with Remedy or comparable tool for asset and
   change management
   - Experience with software such as document management and automated
   testing tools (e.g., First Docs (Documentum), Client Quality
   Center/Application Lifecycle Management).
   - Ability to prioritize and manage multiple projects / efforts
   - Excellent interpersonal skills including ability to work as a team
   member in a collaborative environment with minimal supervision.
   - High attention to detail.


Nimra Nayyab
Technical Recruiter
FAAZ Consulting LLC
Please maintain correspondence electronically- based on the number of phone
call inquiries we receive for every positing it is preferred to send
inquiries via email. It may not be possible to give feedback on every
resume we receive. If your consultant may be a good fit, I would personally
reach out to you.We thank each one of you for helping out and being patient.
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