GE Healthcare · Cork
Sales & Businessposted 11d ago
Perform and oversee routine raw material and packaging component testing in accordance with cGMP, cGLP, and regulatory requirements, ensuring established turnaround times are achieved.
Coordinate raw material testing, approval, release, qualification, and requalification activities while maintaining FIFO inventory practices.
Review analytical data, laboratory documentation, logbooks, and raw data to ensure accuracy, compliance, and data integrity.
Lead or support investigations, deviations, laboratory incidents, vendor complaints, and TrackWise records using appropriate root cause analysis methodologies.
Manage complaint sample testing and reporting, ensuring timely communication of results and material quality issues to internal and external stakeholders.
Monitor laboratory compliance activities, including calibration checks, SOP adherence, archiving requirements, and audit readiness.
Support continuous improvement initiatives through KPI tracking, trend analysis, Lean practices, and implementation of process enhancements.
Act as a senior technical resource within the team, providing guidance to analysts, supporting training activities, and deputizing for the Group Leader when required.
Bachelor's degree or higher in Chemistry, Pharmaceutical Science, Biochemistry, Microbiology, or a related scientific discipline.
Previous experience working within a GMP-regulated pharmaceutical, biotechnology, healthcare, or related manufacturing environment.
Strong understanding of cGMP, cGLP, laboratory compliance requirements, and regulatory expectations.
Experience in analytical testing, material release activities, and laboratory documentation review.
Demonstrated ability to manage multiple priorities while delivering results within tight timelines.
Experience supporting investigations, deviations, CAPAs, audits, and inspection activities.
Strong organizational skills with a proactive and solution-oriented approach.
Willingness to provide flexibility and support business requirements when needed.
Experience with SAP, TrackWise, or similar quality and enterprise systems.
Strong communication and stakeholder management skills with the ability to collaborate across functions.
Excellent problem-solving and root cause analysis capabilities.
High attention to detail and commitment to data integrity and compliance.
Ability to work independently and take ownership of key activities.
Experience driving continuous improvement and Lean initiatives.
Strong coaching and mentoring skills with the ability to support team development.
Adaptability, resilience, and openness to change in a fast-paced manufacturing environment.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Relocation Assistance Provided: No