QA Review / ERP Systems Validation Specialist

Location: Morrisville, NC
Date Posted: 02-16-2018
Title: QA Review / ERP (JDE) Systems Validation Specialist

Location: Somerset, NJ or Morrisville, NC

Type of Role: Contract
Duration: 10-12+ months

Provide QA review/oversight for GXP computer systems validation (ERP System) by conducting the review and approval of executed validation protocols and associated discrepancies for the JDE system.
  • Must have previous experience validating an ERP solution, preferably JD Edwards.
  • Provide QA assessment and approval for GXP computer system changes
  • Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
  • Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
  • Investigates and troubleshoots problems which occur and determine solutions or recommendations for changes and/or improvements and adherence to cGMPs.
  • Reviews, edits and approves change control and SOPs.
  • Strong understanding of the current pharmaceutical industry and applicable regulations, with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 compliance.
  • Strong knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
  • Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions.
  • 7+ years of work experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech or medical device environment.
this job portal is powered by CATS