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Validation and Qualification Lead (Laboratory)

Posted on Aug 27, 2020 by eTeam Inc.

Carlow, Ireland
Research
Immediate Start
€400 - €400 Daily
Contract/Project


Title: Validation and Qualification Lead(Laboratory)
Location: Carlow or Ballydine, Ireland
Duration: 12-15 Months

Job Responsibilities (description of the work):

  • Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
  • Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
  • Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
  • Coordinate alignment of systems users from various company groups on validation and qualification documentation
  • Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
  • Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
  • Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.

Job Qualifications:

  • 7+ years of Lab Systems validation experience is required. 10+ years are desired
  • Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years' experience with LabX method development and validation preferred.
  • Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
  • Understanding of Data Integrity concepts is required
  • Excellent communication and written skills required



Reference: 936657729

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