Offers “Abbott”

19 days agoAbbott

Compliance Specialist (Materials)

  • Cootehill (An Cabhán)
  • Legal

Job description

JOB DESCRIPTION:

About Abbott

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

In Ireland, Abbott employs more than 3,200 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. It has commercial 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 Ireland Nutrition Division – Cootehill

Abbott Nutrition in Cootehill manufactures infant nutritional products for the export markets. The facility is dedicated to providing products of the highest quality standard to its customers.

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.

We are now looking for Compliance Specialist (Materials) and this position will include the following:

The Materials Compliance Specialist is responsible for ensuring that the storage, distribution and manufacturing processes; including product finishing, de-canning process and related processes and advises materials department staff to execute these activities in compliance with the specifications and regulations to ensure Product and Patient safety.

Major Responsibilities

  • Contribute to the development and maintenance of the Abbott quality policies and systems to ensure that business objectives are met for the storage and distribution programs for Abbott Cootehill (Incl. Third Party Warehouse).
  • Continuously supervises the processes related to the assigned quality system(s) and advises staff in relation to this system, on how to execute the applicable activities in compliance with Abbott policies and other applicable regulations, GDP/GMP/FDA/HACCP and ISO standards to ensure product safety and patient safety.
  • Continuously supervises the processes related to the assigned financial and procurement system(s) and advises staff how to execute the applicable activities in compliance with Abbott policies.
  • Maintains the IT system(s) related to the assigned quality system including identification, planning and execution of appropriate training.
  • Support the document control process including the creation of all materials related procedures and policies in line with AQR and AN policies.
  • Continuously evaluates the performance of the assigned quality system and initiates and implements improvement programs.
  • External Auditing - Supports auditors in the effective and efficient execution and documentation, investigation, impact assessment, and corrective/preventive action.
  • Internal/Supplier Auditing - Responsible for performing and follow up of the internal/supplier audit program.
  • Exception Management – Leads and participates in the exception management process.
  • Participates actively in projects that involve Materials, such as NPI projects or implementation of new systems.
  • Materials related Product Finishing activities in line with procedures and GMP.
  • Support all QA related warehouse operations activities.
  • Assuring execution and documentation of housekeeping, cleaning, pest control and security programs.
  • Support complaint handling processes.
  • Participates in Food Safety Team with execution and documentation of HACCP, FSMA and other food regulations.
  • Participates in validation projects; advises regarding classification and requirements for the performance of the validation of the systems/equipment. Reviews and authorizes validation protocols and reports. Is responsible for the final release of a system/equipment upon validation. And as such will participate in the Validation Review Board (VRB).

Supervisory/Management Responsibilities

N/A

Education Required

Degree qualified in relevant discipline.

This is required to understand and manage the complexity of activities associated with the assigned Authorities and Responsibilities.

Technical skills

  • Participation in multi-departmental (international) projects with demonstrated effective communication, teamwork and problem solving skills.
  • Written and verbal communication skills in local and English language.
  • Excellent knowledge of personal computer systems.
  • Well versed in Microsoft Word, Excel and Access.
  • Quality systems, quality assurance experience in an operational setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities is desired.

Knowledge

  • Ideally 3-5 years experience in one or more positions directly related to manufacturing or distribution operations in the Pharmaceutical or Nutritional industry.

Discover why candidates choose a career at Abbott Ireland here

JOB FAMILY:

Supply Chain

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

Ireland > Cootehill : Dromore West

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 38.0Hst0 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Not Applicable