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QA Regulatory Compliance Officer (Permanent)
What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world. We are a $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare. Something remarkable happens when you bring together people who are committed to making a difference - they do!
Reporting to the QA Regulatory Compliance Manager, the QA Regulatory Compliance Officer is responsible for co-ordinating and driving QA systems & Regulatory processes in conjunction with other officers in the Regulatory Compliance team. These processes & systems include IR/CAPA, change control, customer complaints, GMP documentation, internal audits, global standards & policies, GMP training, regulatory submissions, Site Master File/Manufacturing licences, annual reports and PQRs.
The position involves reporting on these systems and providing ownership, coordination, assessment and continuing improvements for these systems/processes. Reporting of data, training and participation in corporate & external regulatory compliance audits as well as upgrading the systems as necessary are integral parts of the role. Providing frontline response to system related queries from other departments is a key function within the role. Manage some of the QMS systems on site, eg vendor complaints process, customer complaints process, change control process, internal audits programme etc Provide support to plant regarding resolution & approval of compliance issues/actions (IRs/CAPAs) & participate in cross-functional teams involved in investigating & supporting resolution of issues Approve of site GMP documentation (validation protocols/reports, analytical reports, SOPs) Conduct QA activities such as preparation/revision of SOPs & training modules and training of personnel Generate/Maintain QMS documentation such as Site Master File, Manufacturing licence, Annual Reports, PQRs & Technical Agreements. Support management of local process to embed & maintain global policies, standards, procedures & best practices Participate in the Internal Audit programme Participate in the Site Inspection Readiness Programme Participate in the organisation of compliance audits from external regulatory bodies (IMB, FDA) and drive timely closure for actions from these inspections Support the GEM refresher & Induction training programmes as well as the Cleanroom Monitoring process Support the development and maintenance of Quality System metrics & support local QA management regarding preparation and execution of Quality Management Reviews Represent QA on development projects and process improvement initiatives Upgrade/Improve the quality systems as necessary from a systematic and compliance perspective Support team members & perform other activities in the areas of GMP compliance & Regulatory Affairs, when required
Appropriate educational background, consisting at minimum of a third level qualification or equivalent. A minimum of 3 years experience in a GMP regulated pharmaceutical environment with experience in managing Quality Systems.
*Self Starter*Ability to work own initiative*Interpersonal Skills*Excellent Communication skills*Attention to Detail
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