Job Information
Abbott Compliance Specialist in Sligo, Ireland
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 114,000 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 over 6,000 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 Sligo
We understand that proper nutrition is the foundation for living the best life possible. That’s why we develop science-based nutrition products for people of all ages. Our products help babies and children grow, keep bodies strong and active, and support the unique nutrition needs of people with chronic illnesses — to make every stage of life a healthy one.
Abbott is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.
Primary Function / Goals / Objectives
Follow all Environmental, Health and Safety Rules and Regulations in the plant.
Report any current or potential hazards to your manager immediately.
Wear the correct Personal Protective Equipment (P.P.E) at all times. Consult the appropriate SOP where required.
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 of Quality & Compliance and other specific areas.
Providing Quality support to Manufacturing, helping to ensure delivery of the highest quality product to the customer.
Key role in implementation and management of the audit readiness in Manufacturing
Develop, identify, analyse, manage and communicate quality & compliance metrics
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.
Manage CAPA activities and product disposition when product is suspect or potentially non-conforming.
Participate as a lead auditor within the plant in internal audit schedule, plant walk-downs and external audits.
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.
Major Responsibilities
Acts as an SME for the CAPA system, involved in Process community and site meetings.
Coordinates quality decisions from a CAPA perspective at the site and ensures compliance to all aspects as applicable.
This role will provide leadership in the areas of quality, plant compliance, strategic compliance, cGMP and Food Safety within Manufacturing. This will include a responsibility in providing direction for continuous improvement.
Develops product quality plans, documents and systems by creating product specification, quality specifications and quality plans in conjunction with Quality, Engineering & Technical. May be responsible for creating risk analyses and failure mode effective analysis.
Participates in corrective and preventative actions.
Participates in complaint investigations.
Participates in validation activity.
Leads process improvements efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance current product monitoring.
Education Required:
Third level qualification in a relevant disciple or relevant combination of education or experience.
4+ years of related work experience
Knowledge
Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
Exercise’s judgement in selecting innovative, practical methods to achieve problem resolution.
Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
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 corpjat@abbott.com