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Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

SUMMARY

The Quality Specialist is responsible to aid the Sandyford Quality Systems department to achieve the Sandyford Site and EMEA Compounding objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Quality Specialist should provide quality assurance expertise and guidance in line with established company and regulatory standards

The Quality Specialist must drive and support a culture of continuous improvement and standardisation within Baxter, whilst ensuring compliance with the Manufacturing license, customer requirements and Baxter requirements.

The Quality Specialist is accountable and responsible for the following activities:

  • Perform investigation of customer complaints, quality defects and reporting of Adverse Events for Pharmacovigilance assessment (PCC - Product Complaint Coordinator)
  • Review and investigation of non- conformances/ CAPA Events and reject / scrap reports and implementation of corrective and preventative actions
  • Coordination and performance of corrective and preventive action investigations.
  • Performance of recall assessment with QP.
  • Ensure products and processes comply with procedures and the principles of GMP
  • Review and approval of process change controls, SOPs and reports
  • Assist in internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
  • Training of Quality and Manufacturing personnel
  • QA data review and compilation of reports
  • Review of quality documentation
  • Development of quality system procedures, controlled documents and processes
  • Risk Management of the quality system and processes
  • Support the site-wide Quality Department
  • Support facility projects including process development and quality improvement initiatives
  • Develop a culture of continuous quality improvement within Baxter
  • Ensure site-wide local systems are in compliance with Baxter and Regulatory requirements
  • Elements of your duties and responsibilities, in terms of routine activities, and specific projects, may span both Baxter Dublin Compounding operations. All such duties/responsibilities are governed by the overarching Baxter Quality Management System.
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
  • Compliance to Environmental Health & Safety (EHS) requirements
  • Refer to Workday for organisational structure

    EDUCATION AND/OR EXPERIENCE

    Required:

  • Degree in Science or related discipline
  • Post qualification experience of at least 2 years
  • Experience of the following would be beneficial:
    • Participation in regulatory and corporate / internal audits
    • Risk Management
    • Working in a project-based environment
    • Experience of implementing changes and process development
    • Previous experience in an aseptic manufacturing facility including practicing Good Documentation Practice

SKILLS

  • Good problem solving and investigation skills
  • Good professional standards, and demonstrates good attention to detail
  • Adaptable to change, e.g. in a project environment
  • Ability to work under pressure and meet deadlines; driven to meet KPIs
  • Highly motivated self- starter and team worker
  • Ability to work in a team based environment and ability to manage a wide range of specific tasks within tight deadlines
  • Flexible
  • Highly organised, good coordination and communication skills

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Quality Specialist

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