Quality Systems Lead - Dublin (IE)
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Authorization awarded by the Health Products Regulatory Authority (HPRA). Sterile batch and patient specific products are manufactured using isolator technology in a clean room environment. The Quality Systems Lead is responsible for ensuring that systems and products manufactured in the Dublin Compounding Facility comply with the Manufacturing Authorization, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.
- Management (Delegation or Performing) of investigation of customer complaints, quality defects and reporting of Adverse Events for Pharmacovigilance assessment.
- Oversight & Management of all Quality Systems on site.
- Responsible for Co-ordination and Execution of Quality Management Review process
- Ensure products and processes comply with procedures and the principles of GMP
- Co-ordination of non- conformances investigations/ CAPA Events reports and implementation of corrective and preventative actions
- Management and supervision of Recall process.
- Review and approval of process change controls, SOPs, validation protocols and reports
- Review and Maintenance of Merlin Component Files and Finished Product Codes
- Leads internal and external audit programs.
- Leads regulatory and corporate / internal audits and performance of supplier audits (as required).
- Training of Quality and Manufacturing personnel
- Development of quality system procedures, controlled documents and processes
- Risk Management of the quality system and processes
- Support facility projects including process development and quality improvement initiatives
- Develop a culture of continuous quality improvement within Baxter
- Approval of Order Entry Error Investigation Reports.
- Ensure site-wide local systems are in compliance with Baxter and Regulatory requirements
- Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
- Compliance to Environmental Health & Safety (EHS) 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.
- Degree in Science or related discipline
- Post qualification experience of at least 4 years
- Experience of the following would be beneficial:
- Previous experience in an aseptic manufacturing facility
- Experience of implementing changes and process development
- Working in a project based environment
- Risk Management
- Leading Teams
- Good problem solving and investigation skills
- Good professional standards, meticulous and demonstrates good attention to detail
- Ability to work under pressure and meet deadlines
- 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
- Good organisational, coordination and communication skills