Quality Assurance Specialist

2 weeks ago

Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time
Job Purpose

The role of Quality Assurance Specialist is to provide strategic, expert advice and consultation on R&D quality with impact across the Good Practices. The specialist will educate assigned groups on Quality by Design, GxP risk minimization and mitigation; and will help the business and GSK's Third Party partners understand potential impact of Quality risks and alternatives to best address the risk.

Key Responsibilities
  • Provide quality business partnership for assigned GSK R&D functions, programs and/or Third Parties supporting Health Care technologies, Invitro devices (IVD's) and lab methods
  • Work closely with business and/or Third Party teams to provide expert quality information, manage identified issues and support continuous improvement particularly in scope of Health Care Technologies, IVDR and clinical lab regulations.
  • Collaborate with the Audit, Inspection, Risk and Issue Management teams within R&D Quality and Risk Management function on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities
  • Support evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio
  • Support issue identification, reporting, root cause analysis and CAPA development
  • Evaluate, and/or review standard operating procedures and perform other activities in support of an integrated, cross functional QMS
  • Provide matrix management and leadership to cross-functional teams
  • Foster a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties
  • Responsible for quality consultation for the assigned function, program and/or Third Party
  • Define, implement and monitor the quality narrative/quality brief and report any critical risk
  • Define the activities that need to be conducted to deliver the quality strategy for the assigned function, program and/or Third Party
  • Support due diligence and Merger & Acquisition activities
  • Ensure rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.
  • Support the investigations of potential serious breaches and critical issues
  • Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT
  • Share key learnings to drive simplification and replicate best practices to drive quality into the business

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