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CSV / QA Validation Review Consultant

Newark, CA · Biotech/Pharmaceutical
Title: CSV/ QA Validation Review Consultant
Type of Role: Contract - 11+ months - Hybrid - Remote / Occasional on-site

Location: Newark, CA
Provide QA review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Manufacturing / Automation and Facilities Systems) by conducting the review and approval of executed validation protocols and associated discrepancies for computerized systems.

  • 8+ 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 environment.
  • Experience with Manufacturing / Automation systems in a Pharma/biotech environment highly preferred.
  • 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.
  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5.
  • 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
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