Quality Specialist - Compounding

About the role

Baxter is hiring a Quality Specialist for its Compounding business, based on-site in Dublin. The role safeguards the quality, safety and compliance of products used by healthcare providers, partnering with manufacturing, technical and operational teams to strengthen quality systems, support regulatory compliance and drive continuous improvement.

Key responsibilities

• Partner with manufacturing, technical and support teams to give quality guidance, resolve quality issues and promote compliance and continuous improvement.
• Lead investigations into deviations, non-conformances, customer complaints and quality events, with robust root cause analysis and effective CAPAs.
• Manage quality system processes such as change controls, risk assessments, documentation reviews and quality records.
• Review and approve quality documentation, validation deliverables, procedures, protocols and reports.
• Monitor quality metrics, trends and environmental monitoring results to identify improvement opportunities and risks.
• Support product lifecycle quality activities, including annual product quality reviews, stability programs, new product introductions and project implementation.
• Contribute to audit and inspection readiness through internal audits, self-inspections, GMP walk-throughs and compliance activities.

Required profile

• Bachelor's degree in Science, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, Quality Management or a related discipline.
• 2-3+ years of experience in a GMP or GDP regulated environment.
• Experience supporting quality systems, investigations, deviations, CAPAs, change controls or compliance activities.
• Preferred: experience in pharmaceutical, compounding, biotechnology, medical device or healthcare manufacturing; knowledge of GMP, GDP, quality risk management and quality systems; audit participation; familiarity with validation, qualification, stability programs, product quality reviews or supplier quality.

Required skills

• Strong problem-solving, analytical and root cause investigation skills, with data-driven decision-making.
• Excellent communication and collaboration skills across functions.
• Attention to detail and ability to manage multiple priorities in a regulated manufacturing environment.