Quality Systems Manager UK, Ireland and Nordics

Quality Systems Manager UK, Ireland and Nordics

Baxter International

Thetford, United Kingdom

Summary:

This role is intended to support and, where possible, improve Quality Management Systems and Processes across the UK, Ireland and Nordics cluster, working closely with the EMEA and ANZ Compounding Quality Organizations. The role will also provide local support for Global Quality initiatives and projects.

This role reports into Head of Quality, UK, Ireland and Nordics with a dotted line relationship to the ANZ Quality Systems Director.

The role will be a nominally based at a UK site, with some home working and travel to UK, Ireland and Nordics sites as required by audits, project support and face to face meetings.

Essential Duties and Responsibilities:

  • Ensure the consistent application of the Baxter Quality System across the UK, Ireland and Nordics Compounding organization:
    • Ensure stakeholders are informed regarding significant QS changes and potential compliance risks;
    • Ensure adequate design, training and implementation of QS changes in the region and early engagement with key stakeholders;
    • Provide guidance documents for implementation of the Baxter Quality System processes/systems in Compounding (best practices sharing across the sites and to build synergy);
    • Compliance support to compounding sites (Quality Audits: Internal and External inspections support, Internal Audit and Supplier Audit execution);
    • Support network wide audit responses and changes to the Quality System as a result of inspection, Baxter Quality Alerts or similar factors;
    • Manage the implementation of the Quality System improvement projects for the UK, Ireland and Nordics Compounding in alignment with Compounding strategy and objectives.
  • Participate in the Compounding Quality System oversight:
    • Collect, analyze, evaluate data and KPI for the UK, Ireland and Nordics Compounding sites;
    • Support Quality Meeting organization.
  • Supervise the Non-Conformity and CAPA process in the UK, Ireland and Nordics Compounding:
    • Monitor the Compounding Non-Conformities/CAPA records and metrics progress;
    • Provide guidance and suggestion as SME and Corporate Expertise council member;
    • Support the country/local initiatives and projects as per request in alignment with the UK, Ireland and Nordics Compounding needs (Integration projects, Cross sites changes, Shared application development, commercial ventures and tenders);
    • Actively contribute to Quality aspects of the UK, Ireland and Nordics Compounding Training system;
    • Deputize for the UK, Ireland and Nordics Head of Quality for document approvals, meeting attendance and other non-critical activities.

Qualifications:

  • People Management skills and ability to work in an international and matrix environment with different tasks;
  • Results oriented with a process and quality driven approach;
  • Self-driven (able to work independently as per needs) and strong motivation;
  • Good communication skills;
  • Project management skills and a proven track record of delivery against targets;
  • Critical thinking and the ability to challenge the status quo;
  • Strong analytical/problem solving skills and a pragmatic approach, hands-on attitude;
  • Positive and proactive approach;
  • A degree in life-science or Engineering, Pharmacy or Chemist or equivalent experience in a Senior Quality Role;
  • 5-7 years industry experience in Pharmaceutical or Medical device related industry;
  • Must have knowledge of Aseptic Processing;
  • Quality System processes and systems knowledge and experience;
  • Thorough knowledge of current EU and UK GMP, particularly with reference to Aseptic Compounding;
  • Excellent level of English (Spoken, Read, Written);
  • Use of standard MS Office applications (i.e. Word/Excel/PowerPoint/SharePoint/Office 365) is a must.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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