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Computer Systems Quality Specialist

SUMMARY

The Computer Systems Quality Specialist is responsible for leading the computer system compliance and data integrity effort at Adaptimmune.  This position will be reviewing procedures, supporting documentations, and validation records to assure that all relevant processes are compliant with applicable policies and procedures.  This position will also participate on the review of computer related change controls and other GxP changes supporting the IT organization.  In addition, this position will serve as the subject matter expert during health authority inspections and internal audits.

 

RESPONSIBILITIES

  • Develop, revise, and maintain Adaptimmune’s Policy on Computer System Validation and Electronic Records and Signature in accordance with current industry standards and/or practices.
  • Assist in developing and maintaining the Data Integrity Policy for Adaptimmune
  • Review computer specifications, validation plans, validation protocols, test results, and summary reports.
  • Participate in multiple system implementation
  • Perform compliance assessment of IT, Quality, Manufacturing, Facility, and Clinical computer related systems in accordance with industry and regulatory requirements for electronic records and electronic signature.
  • Support the quality assurance organization as Subject Matter Expert (SME) for computer systems during regulatory inspections, partner audits, or internal audits.
  • Participate in Change Control and Deviation meetings and provide validation impact assessments for computer or automated systems that require changes.
  • Participate in Computer related risk assessments
  • Collaborate with IT in developing IT policies and procedures to ensure compliance with computer related system policies.
  • Assist and/or lead software vendor audits as a Subject Matter Expert on computer systems
  • Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.

 

REQUIREMENTS

  • Bachelor’s degree in scientific or engineering discipline along with a minimum of 5 years of related experience in the field of computer validation and electronic records compliance and/or Quality Assurance is required.
  • Must have experience in Computer System Validation including development and execution of applicable deliverables which includes but not limited to User Requirement Specification, Validation Plan, Functional Requirements Specification, Design Specification, Requirements Traceability Matrix, Unit, Integration, Installation Qualification, Operation Qualification, Performance Qualification, and Validation Summary Report(s).
  • Must have working knowledge and/or experience in the validation of Manufacturing, Quality, IT, and Clinical computer systems.
  • Must be familiar with SDLC based on GAMP 5
  • Must have experience in providing compliance support and guidance to the IT organization
  • Must have experience is conducting software vendor audits and supporting CRO audits as Subject Matter Expert in Computer Compliance.
  • Must have a working knowledge or familiarity with validation change management and document management processes.
  • Candidate must have excellent organization, documentation, and communication skills.
  • Candidate must have a strong compliance mindset and can work collaboratively and cross functionally in team settings
  • Candidate must be proficient in Microsoft Word, Excel, Power Point, and MS Project.
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