Overview
Compliance Specialist role at 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.
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 SOPs for any job task and ensuring full understanding and adherence.
* 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 contractors 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 & SOPs 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 & Competencies
* A Diploma/Degree in Food Science/Chemistry/Quality or 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 and cross-functional teams.
* 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.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Hospitals and Health Care
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Cootehill, County Cavan, Ireland 1 month ago
Cootehill, County Cavan, Ireland 3 weeks ago
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