QA Specialist

Job Description SummaryThis is an opportunity for a skilled QA Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide. As part of our vision for our manufacturing campus in Cork – of becoming a 50m to 60m unit (vials) capacity parametric release site – we’re set to introduce a new filling line.
Reporting to our Value Stream Quality Leader, you’ll manage the site’s QA systems alongside other specialists in the QA Product Quality team. In particular, your role will involve coordinating and executing all QA duties for the QP batch release. The work you do here won’t just support our growth, it will enable us to deliver our life-changing equipment to even more patients across the globe.

Job DescriptionResponsibilities 
 

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

• Partner closely with customers and stakeholders to understand and deliver on all activities within timelines and escalate when necessary

• 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

• Author, track, manage change, review/approve/authorise relevant documentation types to include, but not limited to; SOPs, investigations, commitments (Regulatory Agency, investigation, audit, etc.), change controls, forms, logbooks, QC stability program, validation and batch release documentation

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

Qualifications and experience

• A degree-level qualification in Science / Engineering discipline or equivalent knowledge and experience

• Previous relevant Quality experience within a QA/QC GMP environment in a Pharmaceutical industry

• Excellent communication and interpersonal skills. 

• An ability to work independently, as well as collaboratively within a team in a dynamic, fast-paced environment. 

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 and 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.

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.

Additional Information