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Computer Systems Validation Consultant

Job ID: 220235

Location: Durham, North Carolina , US, 27517

Summary:

Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry.

Project Details:

  • Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols
  • Write Final Summary Reports that summarize executed qualifications/validations
  • Coordinate validation related activities in regards to equipment and processes

Job Experience:

  • 5+ years of experience in computer system validation.
  • Must have strong Quality and Validation background in CSV.
  • Have working knowledge of 21 CFR Part 11, Data Integrity and GAMP 5
  • Must have experience in the biotechnology, pharmaceutical or FDA Regulated related industry.
  • Bachelor's Degree in engineering, science, or related technology field.
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