Validation Analyst

Illinois  ‐ Onsite
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Keywords

Description

RESPONSIBILITIES:
  • Lead/support validation efforts and deliverables for projects requiring validation.
  • Create and execute validation test scripts and document test results in accordance with standards.
  • Review and evaluate validation assessments for application systems/projects.
  • Review/revise Validation Policy and SOP's as directed.
  • File validation documentation within following Quality Assurance Library guidelines.
SKILLS:

COMPETENCIES:
  • Outstanding verbal and written communication skills, Customer Service Focused
  • Information Technology background, experience within a Quality/Regulated environment; System Audit/Validation background/experience; excellent organizational and project management skills including SDLC.
QUALIFICATIONS:
  • Associate Degree minimum or equivalent combination of education and work experience.
  • Minimum 2 years experience with validated systems within a regulated industry.
  • Experience writing Standard Operating Procedures and validation policies.
  • Advanced knowledge and understanding of IT concepts and word processing and spreadsheet skills.
  • Laboratory, product, and manufacturing knowledge/experience are a plus.
    Must have experience with 21 CFR Part 11
  • Quality Center experience a plus
Start date
n.a
From
Synectics
Published at
31.10.2014
Project ID:
800384
Contract type
Freelance
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