Quality Systems Lead

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The Quality Systems Lead is responsible for for managing and leading the quality release and QS teams to achieve the Sandyford Site and EMEA Compounding objectives.

They should provide quality assurance expertise and guidance in line with established company and regulatory standards

They will be responsible for the implementation and management of the Baxter Quality System within the Compounding Unit

The QS Lead 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. Is responsible for the management of the release process, ensuring product meets specification and the customer order requirements prior to release and is released according to schedule.

To support and facilitate workforce engagement, utilising EMS, and staff development through objective setting and suitable development plans.

Essential Duties and Responsibilities

The Quality Systems Lead is accountable and responsible for the following activities:

Document and Data Management

• Ensures all procedures are controlled and current versions are available to staff as required
• Ensures there are no unauthorized changes to documents including creation of local documentation.
• Ensures all documentation is relevant and applicable to the process and is reviewed and updated.
• Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
• Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible
• Responsible for the review and approval of new and updated procedures, controlled documents and processes
• Drive and support standardisation across the EMEA Compounding Units.

Quality System Management and Review

• Responsible for the completion of the Quality Management Review meetings and the Annual Product Quality Review
• Ensure outcomes, decisions and actions of the review are documented
• Ensure meeting actions are completed to agreed deadlines
• Report monthly quality KPI to  UK/Ireland QA Manager.
• Review of quality documentation. QA data review and compilation of reports
• Ensure systems are in place to track and trend quality system data and indicators, including but not limited to CAPA and Complaints. Trending should include timeliness in completion as well as actual numbers.
• Ensures appropriate Risk identification and management processes are implemented in the compounding unit

Audit Management

• Ensuring site-wide local systems are in compliance with Baxter Corporate and Regulatory requirements
• Ensures the site has a process for internally reviewing the compliance status and is prepared for an audit at any time
• Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit
• Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
• Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue

Other Responsibilities and Duties:

• HPRA contact for the Manufacturing Licence and compounding issues
• Provide support to the site wide Quality Department
• 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
• Support compliance to Environmental Health & Safety (EHS) requirements
• Maintenance of professional status and standards
• Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
• Compliance to Environmental Health & Safety (EHS) requirements
• Refer to BaxWho for organisational structure

Qualifications:

• Degree level qualification or equivalent in an Engineering or Science Discipline.
• Minimum 2 years experience in a quality related role within a regulated industry.
• Minimum 2 years people management experience.

SKILLS

• High Attention to Detail                                
• Pro-active approach to Work
• High Standards                                             
• Flexible
• Excellent Communication Skills
• Influencing Skills (Written & Oral)                             
• Team Player                                        
• High Level of Numeracy                 
• Highly Computer Literate                   
• Planner & Organiser                                     
• Highly Motivated

“What are some of our benefits of working at Baxter?

• Pension
• Health Insurance
• Life Assurance
• Baxter is committed to growing and developing their workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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