GE Healthcare · Cork
Otherposted 3w ago
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 escalate. 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.
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.
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.
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 a culture that fosters care, collaboration, and support.
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Relocation Assistance Provided: No