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QA Specialist

GE HEALTHCARE -
Cork, County Cork

Apply Now

Job details

Qualifications

Engineering
English
Communication skills
Negotiation

Full job description

Job Description Summary

This 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 Description

Responsibilities

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

Relocation Assistance Provided: No

Apply Now

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regulatory specialist jobs in county cork

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