Compliance Specialist

Job description

JOB DESCRIPTION:

· 

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, nutritional and branded generic medicines. Our 107,000 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 nutritional products. In Ireland, Abbott employs over 4,000 people across nine 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, Southeast 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.

Major Responsibilities

·  This role will provide leadership in the areas of Plant Compliance, Strategic Compliance initiatives, cGMP and Food Safety within Manufacturing.  This will include a responsibility in providing direction for continuous improvement. 

Primary Function / Goals / Objectives

·  Play an active role in the Food Safety Management Team with responsibility for the HACCP Programme.
·  Responsibility for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
·  Lead strategic quality initiatives in the areas Compliance and other specific areas.
·  Key role in implementation and management of the audit readiness in Manufacturing
·  Develop, identify, analyse, manage and communicate compliance matrices
·  Ensuring Compliance to all Regulations/Legislation applicable to Manufacturing.
·  Develop and deliver training with regard to compliance based on business needs. 
·  Play a key role in the Plant Compliance to ensure all new equipment/processes and any new infrastructure meets cGMP standards and regulatory compliance.
·  Ensure compliance to all Corporate and Division Policies in the area of responsibility.
·  Benchmark activities to ensure current cGMP is consistent with Infant Formulae Nutritional Industry.
·  Manage CAPA activities and product disposition when product is suspect or potentially non-conforming.
·  Responsible for auditing of the Manufacturing Department.
·  Participate as a lead auditor within the plant in internal audit schedule, plant walk-downs and external audits.
·  Manage and co-ordinate bi-weekly compliance walk-down programme activities.
·  Play a key role in ensuring the plant is audit ready for CRQS, Division and regulatory audits.
·  Responsible for the oversight of the plant sanitation programme and liaising with third party cleaning contractor who have responsibility for cleaning, sanitization, Environmental Monitoring Programme and pest control.
·  Accountable for compliance to all local and US federal regulations, all applicable food safety policies and procedures.
·  This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made.
·  This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises. 

Education Required:

·  A Diploma/Degree in Food Science/Chemistry/Quality or a Third level qualification in a related discipline.

Knowledge

·  Very good understanding of the manufacturing process.
·  Strong knowledge and experience in auditing, analytical techniques and methods used.
·  Excellent interpersonal skills and management skills.
·  Ability to:
·  Communicate with all levels of the organization.
·  Communicate effectively with cross-functional team.
·  Recognize and reward effort.
·  Resolve conflict constructively.
·  Seek feedback.

Accountability / Scope

·  This function will have responsibility to ensure that Compliance is managed effectively and will provide leadership in the areas of Manufacturing Compliance, Strategic Compliance initiatives, cGMP and Food Safety. 

Connect with us at  www.abbott.com or https://www.ie.abbott/ , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at  www.facebook.com/Abbott  and on Twitter @AbbottNews .

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

Ireland > Cootehill : Dromore West

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Chsal39 (Ireland)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable