Shift QA Specialist

MS0234 GE Healthcare Ireland Limited; Cork; On-site; EUR 60,000 - 75,000; Full time

Job summary

GE HealthCare in Ireland seeks a Shift QA Specialist to ensure GMP compliance, drive quality excellence, and support batch release across manufacturing. You will collaborate with Operations and QC, lead investigations, CAPAs, and participate in continuous improvement initiatives to maintain cGxP compliance.

The role requires a science/engineering qualification, extensive GMP/QA experience, and eligibility to act as a Qualified Person. English proficiency and work authorization are essential.

Qualifications

• 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.

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.

Skills

GMP/QA experience

Qualified Person eligibility

Interpersonal communication

Education

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

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.

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Additional Information

Relocation Assistance Provided: No At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.