Senior Internal Auditor
2 weeks ago
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs o6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Ireland Nutrition Division Cootehill Cavan
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow on formulae under the brand name of “Gain”. The essential ingredient is liquid skim milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.
Primary Function
The primary function of this role is to implement and maintain an effective Internal Audit Program. You will direct, facilitate, and lead site Quality System and Good Manufacturing Practices (GMP) audits to assess compliance with applicable regulations and policies, and communicate any gaps. Additionally, you will provide direction, support, leadership, and management of compliance with Federal Regulations, International Standards/Directives, or other applicable governing bodies and Abbott Policies as they relate to quality management, audits, manufacturing, manufacturing support, and CAPA management. Keeping auditing techniques and skills current through training and staying updated with regulatory standards, best practices, and Quality System expectations is essential. You will also execute the audit readiness plan for external audits and inspections,
Main Responsibilities
- Implement an effective Internal Audit Program through execution of the following activities:
- Plan and lead quarterly Quality System (QS) and Good Manufacturing Practices (GMP) risk-based internal audits for adherence to applicable regulations, standards, and Quality System expectations.
- Carry out risk-based audit planning and preparation.
- Mine applicable data to identify risks including review of corrective actions and commitments to ensure properly implemented and sustained.
- Follow up on CAPA actions to ensure completion on time.
- Exercise independent, expert judgment to provide direction and management to all departments regarding risk and resolution.
- Serve as a neutral partner, achieve a balance of involvement and objectivity, and prioritize GMP compliance.
- Provide and execute an annual internal audit schedule by assessing compliance of the systems and facilities.
- Provide feedback (or direction) in the form of audit observations, formulating recommendations and determining if corrective actions and commitments have been properly implemented and are effective.
- Monitor compliance metrics through Continuous Improvement Meetings, Annual Product Reviews and Quarterly Management Reviews and monthly reports.
- Plan, coordinate internal activities and communicate to notified bodies to ensure applicable registration / certification status.
- Participate and/or lead internal and external site audits as required.
- Train to continuously update auditing techniques and skills related to the following areas and keep current with regulatory standards, best practices, and Quality System expectations.
- Act as the lead for global audit findings review and manage the Global Impact Assessment Review (GIAR) process.
Education Required
- You will have a Degree from a relevant discipline or equivalent combination of education and work experience.
- A minimum of 3 years Auditing experience in a relevant industry
- A minimum of 3 years Quality Assurance experience in nutrition/regulated industry.
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