QA Specialist

GE HealthCare; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

GE Healthcare in Cork, Ireland, is seeking a QA Specialist to manage QA systems and support QP batch release for X-ray and MRI contrast media. You will work within the QA Product Quality team to ensure compliance with GMP and QMS while driving improvements and document control.

The role requires a degree in Science or Engineering and strong communication skills, with the ability to work independently and collaboratively in a fast-paced pharma environment.

Qualifications

• A degree-level qualification in Science / Engineering discipline or equivalent knowledge and experience.
• Previous relevant QA/QC GMP experience in a pharmaceutical environment.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a dynamic team.

Responsibilities

• Ensure GMP, QMS, site policies and regulatory requirements are met.
• Partner with customers and stakeholders to deliver activities on time.
• Lead cross-functional teams to provide quality-related consultative support.
• Lead investigations and CAPA actions to prevent recurrence.
• Prepare and manage documentation including SOPs, changes, and batch release files.
• Manage metrics and forums to ensure delivery of site KPIs.

Skills

Quality assurance

GMP knowledge

Excellent communication

Independent & collaborative work

Education

Science or Engineering degree

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.

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.

As the QA Specialist, 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.

Responsibilities

Job Description

• 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 elevate 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