Compliance Specialist

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 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 nutritionals products.

In Ireland, Abbott employs over 6000 people across tensites.

We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, 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 Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses.

Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.

Our broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels.

These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.

Purpose of the Job

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.

Major Responsibilities

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.

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.

Manage the Manufacturing Department Janitorial requirements and staff.

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.

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.

Responsible for reporting of the site sanitation programme performance at monthly management review and through management activities.

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 were this need arises.

Education & Competencies

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

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.

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.

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