QA Specialist/Qualified Person

6 days ago

Cork, Cork, Ireland GE HealthCare Full time
Job Description Summary

Join GE HealthCare's Medical Diagnostics team as a QA Specialist/Qualified Person, where you'll play a key role in ensuring our QA activities meet global regulatory standards. Collaborating with dynamic internal teams—like Manufacturing, Supply Chain, and Regulatory Affairs—and engaging with external partners including distributors, suppliers, and regulators, you'll help drive excellence and compliance across our operations in a fast-paced, impactful environment.

Responsibilities

Job Description
  • Provide quality assurance oversight on all X Ray & MRI products manufactured by GEHC, Cork covering all stages of product lifecycle i.e. preparation, manufacture, testing, packaging, labelling, storage, transportation, distribution, complaint handling, documentation and record keeping.
  • Work with other internal support functions to ensure all processes are designed, implemented and maintained to meet relevant requirements.
  • Manage the batch record review and final QP disposition of manufactured batches as per Annex 16 release requirements.
  • Review complaints as required related to GEHC Cork and take appropriate action to prevent recurrence.
  • Involvement in regular audits to assess the effectiveness of quality systems, identify any non-conformances and recommend corrective actions.
  • Maintain accurate records of all quality assurance activities.
  • Coordinate the conduct of investigations into quality issues identified through internal or external sources.
  • Collaborate with distributors and customers on quality matters.
  • Actively participate in cross functional investigations/projects as required.
  • Ensure timely communication and reporting to senior management regarding significant product quality issues.

Qualifications And Requirements
  • Bachelor's degree (2.1 or above) in a relevant discipline such as: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or equivalent
  • Strong experience in a Quality Assurance role within a Life Sciences industry.
  • Strong knowledge of cGMP requirements, EU Directives & Regulations 2001/83/EC, Eurdralex Volume 4, specifically focusing on Annex 13 & Annex 16 requirements .

Desired Skills
  • Advanced computer skills, particularly Microsoft Office Suite, Excel. Familiarity with validated quality systems e.g. Trackwise Digital, Veeva Vault and Compliance Wire a bonus.
  • Proficiency in written and spoken English language essential.

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.

Behaviors

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.

Total Rewards

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

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