QxP Quality Systems

  • location: Elkton, VA
  • type: Contract
  • salary: $45 - $50 per hour
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job description

QxP Quality Systems

job summary:
Exciting opportunity for a long-term CSV project in Elkton, VA!

 
location: Elkton, Virginia
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Review all Automation/IT CSV project and system deliverables including but not limited to:

    • Plans
    • Requirements
    • Specifications
    • Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
    • Summary Reports
    • Change Controls
  • Review system operational and administration procedures to ensure they are adequate
  • Document any findings of non-compliance
  • Assist with remediation approach where required
  • Assist with review of remediation activities
 
qualifications:
  • Computer System Validation (CSV) experience in Life Sciences
  • An understanding of 21CFR Part 11 and Annex 11, ISO 13485, 21 CFR 820, 21CFR 210, 21 CFR 211
  • Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements
  • Understanding of Information Technology quality management systems (i.e IT governance procedures) and system development life cycle processes
  • Experience with quality assurance activities for the system development life cycle and CSV
  • Understanding of manufacturing and equipment systems and software (e.g. Manufacturing Execution Systems)
  • Strong written and verbal communication skills
  • Strong interpersonal skills
  • Approximately 4-6 years' experience in the above skills
 
skills: Data Validation Plan
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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    QxP Quality Systems

  • location: Elkton, VA
  • job type: Contract
  • salary: $45 - $50 per hour
  • date posted: 9/9/2019