Shift QA Specialist

gehc; Cork; On-site; EUR 65,000 - 90,000; Full time

Job summary

GE HealthCare in Cork, Ireland is seeking a Shift QA Specialist to uphold GMP, quality systems and regulatory compliance across manufacturing operations. You will collaborate with Operations and QC to drive quality excellence and support batch release activities.

In this role you will lead investigations, CAPA actions, change controls and documentation reviews, while mentoring teams and guiding continuous improvement.

Qualifications

• 3rd level qualification in Science / Engineering discipline or equivalent knowledge or experience.
• Significant GMP/QA experience in a pharmaceutical company or similar regulated environment.
• Eligible to act as a Qualified Person per local and EU directives.

Responsibilities

• Ensure compliance with GMP, Quality Standards, QMS, site policies/procedures, regulatory requirements and industry standards.
• Represent Quality at Tier 1 & 2 meetings with Operations and QC, communicating concerns and tracking actions.
• Support GMP/GDP documentation review and GEMBA checks highlighting cleaning standards and documentation completion.
• Complete batch record reviews for QA as required.
• Provide governance for GEMBA housekeeping, action tracking and escalation.
• Lead investigations and CAPA, ensuring root cause analysis and preventive actions.
• Review, authorise and manage changes, SOPs, investigations, and batch release documentation.
• Provide QA support for shutdown actions and site metrics.
• Lead cross-functional continuous improvement teams to address quality issues.

Skills

Interpersonal skills

Communication

Problem solving

Continuous improvement

Education

3rd level qualification in Science / Engineering

Job description

Job Description Summary

As a Shift QA Specialist at GE HealthCare, you will play a key role in ensuring the highest quality and compliance standards across our manufacturing operations. Working closely with Operations, QC, and cross-functional teams, you will drive quality excellence, support batch release activities, proactively identify and resolve quality issues, and help ensure our life-saving products are delivered safely and compliantly to patients around the world.

GE HealthCare's Pharmaceutical Diagnostics (PDx) segment develops and manufactures contrast media and radiopharmaceutical imaging agents used across X-ray/CT, MRI, ultrasound, SPECT and PET. PDx products support diagnostic pathways in neurology, cardiology and oncology, are used by healthcare professionals in more than 130 countries, and support approximately 140 million patient procedures each year - equivalent to four procedures every second.

Job Description

Responsibilities

Ensure compliance with GMP, GE Healthcare Corporate Standards, Quality Management System (QMS), site policies/procedures, regulatory requirements and industry standards

Represent Quality at Tier 1&2 meetings (Operations and QC) providing updates and communicating any concerns, escalations and ensuring any quality compliance related actions are tracked at the Tiers.

Support spot checks on GMP/ GDP review into documentation through GEMBA check/ review/ advise to standards highlighting focus areas such as cleaning standards, PIR, documentation completion etc

Complete batch record reviews for QA as required

Provide governance oversight for the housekeeping GEMBA process and walkthroughs in QC and Operations driving compliance to processes and procedures ensuring focus on cGxP mindset. Coordinate walks with QC and operations and support functions. Document, communicate and track completion of action items, trend and elevate. Holding area owner accountable and responsible for raising SR's and completion of tasks.

Ownership for Instruction Monitoring process governing monthly meetings to review monthly data and any trending of issues to ensure operations actions are assigned.

Provide support for escalations as QA primary point of contact in operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business needs, which may result in Deviation/ Investigation support, escalation and containment

Lead & support cross functional/continuous improvement teams as required to provide consultative and collaborative support on quality related issues

Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant

Review, author, manage change, authorise relevant documentation types to include, but not limited to; SOPs, investigations, commitments (Regulatory Agency, investigation, audit, etc.), change controls, forms, logbooks, validation and batch release documentation

Provide Quality support for shutdown actions and activities to ensure areas shutdown and start back up compliantly

Lead & support management of relevant metrics/forums to ensure ownership and delivery of, and compliance with, key site metrics

Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.

Qualifications and experience

3rd level qualification in Science / Engineering discipline or equivalent knowledge or experience

Significant experience within a GMP / QA environment in a pharmaceutical company or similar regulated environment

Eligible to act as a Qualified Person in line with local and EU directives.

Desired Skills

Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization

Excellent communication, negotiation and risk-based decision-making skills, promoting openness, dialogue and collaboration

Results oriented with a strong ability to effectively troubleshoot, and problem solve issues

Promote a continuous improvement culture.

Eligibility requirements

A good level of English and a valid work permit

Inclusion & Diversity

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 expression, 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