Shift QA Specialist: GMP & Quality Excellence

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

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.