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Quality Systems Specialist

Quality Systems Specialist

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Quality Systems Specialist

  • Location:


  • Sector:

    Research & Development - Pharma

  • Contact:

    Anjali Kalairajah

  • Salary:


  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    about 1 year ago

  • Startdate:


Quality Systems Specialist, North England, Contract- Ongoing, Competitive Pay Rate!

Key Responsibilities include:

  • Oversee the global supplier qualification and assessment activities per established procedures, including initial on-boarding (including Quality Agreements), maintaining the supplier files and approved supplier list

Analyse and Facilitate Supplier Change Notifications, Deviations and Corrective Actions

  • Support implementation and closure of supplier change notifications
  • Provide support and expertise for global sites for any quality issues encountered from suppliers
  • Facilitate root cause analysis and corrective actions of supplier quality issues (deviations) and support through on-site supplier visits, if applicable, for root cause analysis and verification of correction actions of supplier quality issues
  • Work with the supplier directly to create correction action plans to address quality failures and issues

Develop and report on Key Performance Indicators

  • Develop and report on supplier quality Key Performance Indicators (KPIs) driving to optimise performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or system.

Quality Partnerships

  • Support Operations, Supply Chain, Supply Chain QA, Procurement and QA leaders with the qualification and management of suppliers and service providers to ensure they consistently meet GxP requirements
  • Represent Supplier Management in cross-functional teams to develop successful partnerships for consistent GxP-compliant supplier oversight.
  • Partner with the Quality Compliance Auditing/Inspections team to ensure any requested data is available to support external audits.
  • Represent Supplier Management in external audits by regulators/customers and ensure any Supplier Management related observations are addressed appropriately and timely. Support remedial actions (e.g. CAPA) with operational areas of the business.

Continuous Improvement

  • Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance.

Regulatory Intelligence

  • Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the sites.
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