JOB DESCRIPTION SUMMARY

Are you passionate about quality and looking to make a real impact in a dynamic environment? We’re looking for a QA Associate to join our team, reporting directly to the QA Lead.
In this role, you’ll play a key part in ensuring that all batch release activities are completed efficiently, on time, and in full compliance with regulatory standards. Your work will directly support our commitment to delivering high-quality products and excellent customer service.
You’ll be a vital part of the value stream, helping us meet and exceed quality expectations while collaborating with cross-functional teams to ensure smooth and timely product delivery.
GE HealthCare Ireland Limited manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE HealthCare, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time here at our campus at Carrigtohill, Co. Cork.
Every second of every day, 365 days a year, a patient is diagnosed with the help of our products through procedures such as X-Ray and MRI. We are a modern, agile, cost competitive team delivering to the highest standards of safety, quality, and compliance to patients around the world.

QUALIFICATIONS AND REQUIREMENTS

• You have achieved at least a Professional Level 8 degree qualification
• Experience working within a GMP environment
• Ability to work on own initiative & judgement with minimal supervision
• Clear thinker who can analyze data to establish a direction to proceed
• Relevant working Knowledge of a regulated Industry
• Highly organised and attentive to detail
• Capability of handling multiple tasks effectively and meeting critical deadlines
• Strong verbal and written skills
• A high degree of computer literacy

• Quality Assurance: Keep colleagues informed of current issues and developments as appropriate. Ensuring compliance with all regulatory/company guidelines. Adhering to Operational Excellence within the QA Department
• Process Improvement: Support quality improvement initiatives to continuously improve QA processes, methodologies, and tools to enhance efficiency and effectiveness.
• Daily Management System: Maintain the retention program from a Quality perspective. Maintain departmental metrics ensuring on time batch release is consistently achieved. Generation/ reporting of Key performance indicators for the group as required.
• Batch Release: Support the quality review of batch related documentation prior to certification by QP in accordance with GMP regulations. Review and approve deviations & investigations related to product quality to support timely closeout of quality records.
• Collaboration: Collaborate with cross-functional teams to ensure seamless communication and understanding of quality objectives and ensure appropriate action is taken to support on site investigations. Liaising with internal and external customers e.g., planning/ QA/ Production etc.
• Training and Development: Provide training as required to team members to enhance their technical skills and knowledge of QA practices. Perform cross training in order to ensure flexibility within the QA department. Ensure all training is current and completed on time.
• Risk Management: Identify and assist in mitigating risks ensuring timely resolution of issues.
• Documentation: Management of site archive, storage, retrieval and destruction processes
• Audit Readiness: Assure site and business is properly prepared for external and internal compliance inspections. Support and participate in site internal audits, Regulatory audits and third party audits. Collaborate closely with business partners to ensure site is audit ready at all times
• Ensuring compliance to company administrative procedures and policies in the department
• Ensuring compliance with EHS at all times, and actively participate in EHS activities.
• Approving validation documentation and ensuring Validation activities are carried out in compliance with, cGMP and company Quality standards
• Completing a reasonable level of overtime as required to facilitate the business needs.
• Carrying out additional duties as deemed necessary by the Quality leader.