QA Review / Lab Systems Validation Specialist

Location: Morrisville, NC
Date Posted: 09-15-2017
Title: QA Review / Lab Systems Validation Specialist

Type of Role: Contract - 12+ months

Location: Morrisville, North Carolina
Provide QA review/oversight for GXP computer systems validation (focus on Laboratory Systems) by conducting the review and approval of executed validation protocols and associated discrepancies for computerized Laboratory systems.

•        Experience with Lab Systems, ie. Waters NuGenesis, Empower SDMS, LabVantage or LabWare LIMS 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.
•        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.

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