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Quality Specialist, Computerized Systems Quality and Management
Boston, MA  Posted: 1/8/2020


TITLE/ROLE:  Quality Specialist, Computerized Systems Quality and Management
This position will be responsible for supporting the Computerized Systems Quality and Management (CSQM) group, working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement. This role will review and approve computerized system lifecycle documentation as well as provide GAMP, Part 11/ Annex 11, and data integrity expertise to key stakeholders internal to Vertex.
  • Develops understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas.
  • Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
  • Reviews and approves system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas
  • Consults with CSQM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
  • Identifies and escalates areas of risk or non-compliance to manager / leadership team
  • Participates in performing Periodic Review activities of Computerized Systems
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities
  • Bachelor's degree and relevant GxP work experience,
  • 6-10 years of related experience
  • Proficiency in using Microsoft Office applications
Experience with the following:
  • Performing Quality Assurance function related to Computerized Systems / Infrastructure
  • Proficiency with regulations related to FDA / MHRA regulations
  • Use of computerized quality management systems
  • Experience with validation of Enterprise / Lab Computerized Systems.
  • Quality metrics, dashboards, analysis and improvement programs
  • Knowledge of GAMP and Agile validation lifecycle and methodologies.

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