Abbott Senior Supplier Auditor(Quality) in Sligo, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a Third Party Manufacturing operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Diagnostics Division (ADD)
Abbott established the first diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents. In 2004, Abbott Diagnostics operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004. Manufacturing commenced in March of the following year and the first product (Architect TSH) was launched in December of 2005. These facilities play a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.
We currently have a vacancy for a Senior Supplier QA Auditor and this role will involve the following:
Primary Job Function:
Reporting to the Manager of Global Compliance and Auditing the Senior Supplier QA Auditor independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM) to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits. He/She may participate in audits of manufacturing and commercial affiliate sites. He/she will be involved in projects that are cross-functional/cross-divisional in scope as Subject-Matter-Expert (SME).
Core Job Responsibilities:
Independently conducts and leads audits across ADD's Supplier and TPM network.
Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.
Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues.
Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
May assume managerial responsibilities as needed
- Degree preferably in science or technical discipline such as biology, chemistry, engineering, or Certification in Medical Technology or Quality Management.
Minimum Training /Experience
Trained at a minimum as a Certified Auditor with working knowledge of Good Manufacturing Practices (GMP’s), Quality Systems standards and regulatory requirements such as 21 cfr 820, 21 CFR Part 600, ISO 13485 and IVDD.
Minimum of 5 years experience in pharmaceutical or medical device industry or other regulated industry.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com