Global QA Specialist – Global Audit and Compliance

1 maand geleden

Weesp, Nederland Abbott Voltijd

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 action

Minimum 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 11

How do you apply?

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