Validation Analyst

Illinois  ‐ Onsite
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Description

Job Description:
Activities include the qualification, validation and remediation of GxP laboratory instrument systems to be commissioned for use in clinical drug development applications. The candidate must understand laboratory instrument system data handling and information technology (IT) principles for analysis of electronic data flows, from data collection to data archival in interfaced validated quality systems. Qualifications/validations must meet current electronic data integrity requirements according to 21 CFR Part 11 and related regulatory guidance.
Responsibilities:
  • Establishing a range of instrument system life cycle aspects by helping to build validation change control packages related to electronic data flow: instrument system IQ/OQ/PQ, validation protocols, test scripts, documenting results, and revising standard operating procedures.
  • The candidate will visit analytical laboratories on occasion for collaborative purposes only. No lab work is required.
  • 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:

Skills/Qualifications:
  • 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.
  • 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.
  • 4-6 Years Experience.
Start date
n.a
From
Synectics
Published at
22.07.2015
Project ID:
950257
Contract type
Freelance
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