JOB DESCRIPTION SUMMARY

In this dynamic role, you’ll take ownership of key Quality Assurance systems—including Deviations, CAPA, Change Control, customer complaints, GMP documentation, audits, training, and regulatory reports—driving continuous improvement and ensuring compliance with global standards. You’ll be the go-to expert for system-related queries, lead data reporting and training initiatives, and play a central role in both internal and external audits, while actively upgrading and enhancing QA processes to support a high-performing, compliant manufacturing environment.

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
• Participation in QA System Implementations for QA Department & support roll out to the site.
• Management of the QA compliance systems, such as IR/CAPA, change control, customer complaints, GMP documentation, internal audits, global standards, policies & procedures, GMP training, technical agreements, PQRs and vendor/supplier management.
• Provide support to plant regarding resolution & approval of compliance issues/actions (Deviations & CAPAs) & participate in cross-functional teams involved in investigating & supporting resolution of issues.
• Approve site GMP documentation (validation protocols/reports, analytical reports, SOPs).
• Conduct QA activities such as preparation/revision of SOPs & training modules and training of personnel.
• Support management of local process to embed & maintain global policies, standards, procedures & best practices.
• Participate in the Site Inspection Readiness Programme & the internal auditing function as appropriate.
• Participate in the organisation of compliance audits from external regulatory bodies (e.g. HPRA, FDA) and drive timely closure for actions from these inspections.
• Support the development and maintenance of Quality System metrics & support local QA leadership team regarding preparation and execution of Quality Management Reviews.
• Represent QA on development projects and process involvement initiatives.
• Identifying and building efficiencies into the compliance systems as necessary from a systematic and compliance perspective.
• Frontline response to system related queries from all departments.
• Support team members & perform other activities in the areas of GMP compliance when required.
• Support the Platforms (Packaging/Production) structure in the areas of GMP compliance when required.