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Global QA Specialist – Global Audit and Compliance
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Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
The Global QA Specialist – Global Audit and Compliance is responsible for providing QA general support for the evaluation of the compliance status of Global GMP/GCP Suppliers, Third-Party Manufacturers (TPMs), Contract Manufacturing Operations (CMOs) and EPD Internal Manufacturing sites/locations that fall under the responsibility of EPD Global Audit.
The position reports to the Associate Director QA Global Audit and Due Diligence
The function serves to support a strategic global purpose for Abbott, with responsibility for GMP/GDP/GLP Global Audit program. The function leads and manages the Global Audit schedules (internal and external), as well as support with due diligence activities for product acquisition and in-licensing deals. Position also provides support for Global Auditor/Divisional Goals and initiatives.
The individual interacts with Division functions (Global Supplier/TPM QA, Global I&D QA, Global Distribution QA, Division Compliance) as well as with Regional and site functions for audit/project/metrics related activities
Core Job Responsibilities
Manage back office Global Audit work related to audit scheduling, audit preparation coordination with all relevant stakeholders, audit record updates in Trackwise, audit data analysis and metrics management. Ensure that annual Global Audit schedules are created, in alignment with all relevant stakeholders, issued and regularly updated Support with the management of audit exceptions (i.e. missed audit frequency) and with completion of timely completion of any actions assigned to Global Audit Ensure that all audit related information is documented into the Audit Tracking system in a timely manner. QA support for all elements needed to facilitate new Licenses and Acquisition deals and associated product launch. Support with all activities required to plan, execute, report and close the audits assigned to Global Auditors Support with creation/update of supplier agreement with audit service providers in alignment also align with Global Legal requirements Manage time management system (Planisware) setup and updates for all Global Audit team Support with the review of Quality Questionnaire returned by the Suppliers/TPMs and resolve any issue, where required Support with timely completion of post audit activities (i.e. CAPA follow-up, scheduling of follow-up audits) for supplier and TPMs globally. Timely information of any audit refusal received by Suppliers of TPMs and support with any proposed remediating/mitigating actionMinimum Education and Experience
Bachelor Degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries 5-7 years in the Pharmaceutical Industry and/or Government Regulatory Agency, including GXP Auditing experience and knowledge of GMP and ISO. Knowledge of Pharmaceutical Quality System Knowledge and understanding of the FDA, EU or other relevant GMP guidelines and ICH and other relevant technical guidelines Understanding of the WHO and other applicable regional and local regulations Good Communication skills Advanced written and verbal skills in Business English Awareness of intercultural differences Basic understanding of CFR part 11 and/or EU Volume 4, Annex 11How do you apply?
