Snr Quality Systems Associate,

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

The Senior QS Associate will be responsible for leading and supporting initiatives to ensure the continuous compliance of the UK Compounding business to cGMP and “Specials” manufacturing requirements, local procedural requirements, and Baxter Corporate policies. This role will focus on providing quality systems support across the UK compounding network. Reports into the UK Compounding Quality System Manager. You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior QS Associate, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it’s building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What You’ll Be Doing

• Ensure compliance with applicable GMP, GDP, MHRA, and other relevant regulatory standards.
• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with corporate and regulatory requirements.
• Stability and Temperature Excursion Management
• Review Baxter stability studies, product SmPCs, and relevant scientific literature to define compounded product stability data.
• Assess and document temperature excursion incidents within the Quality System.
• Own and lead Temperature Excursion Evaluation Tasks, ensuring timely and thorough investigation.
• Review and approve temperature excursion documentation and provide product disposition assessments.
• Support the management of stability records in the Pharmacy electronic systems Merlin and Mercury.
• Raise significant excursions through the nonconformance process.
• Ensure regulatory reporting of issues to local Regulatory Authorities as required.
• Field Actions and Recalls
• Lead and coordinate field actions and product recalls in accordance with Baxter procedure.
• Ensure effective communication and documentation throughout the recall process.
• Liaise with internal and external partners such as MoH, Baxter Compounding Units, Baxter Commercial and Medical Affairs teams, Baxter Homecare, etc.
• Collaborate with cross-functional teams to assess impact and implement corrective actions.
• Lead and raise significant quality issues within the Global Compounding Organization for the purposes of Senior Management and other Compounding sites awareness.
• Audit Management
• Lead and support Internal, Corporate and external/Regulatory audits.
• Support site’s audit readiness activities.
• Lead and support in the annual internal audit program as required.
• Track and trend relevant unit audit findings.
• Other duties you will also be involved in as part of the role:
• Introduction of New Drugs and Components.
• Change Control Process.
• Corrective & Preventive Action Processes.
• Documentation.
• Quality Management Review (QMR).
• Communication and Training.

What You’ll Bring

• English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5.
• At least 2 years’ experience in the pharmaceutical or medical device industry.
• Proven knowledge of Quality System processes.
• Bachelor’s degree or higher in Pharmaceutical, Biotechnology, Chemistry or Microbiology.
• Minimum of 2 years' experience in quality team facilitation, project management, process improvement, or quality data analysis role.
• Experience of coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance, and Complaints processes.
• Experience of problem-solving using Root Cause Analysis techniques such as GEMBA, 5 Whys, Cause and Effect.
• Working knowledge and hands-on experience of software tools to lead Quality Systems processes such as TrackWise.
• Report and documentation writing skills.
• Risk management tools and methods.
• Excellent verbal and written communication skills.

What are some of the benefits of working at Baxter?

• Competitive total compensation package.
• Professional development opportunities.
• High importance placed on work life balance.