- Ensures compliance to the requirements from regulatory agencies.
- Maintains the technical and non-technical documentation change system.
- Assures procedures are in place to classify and maintain records.
- Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
- May identify submission components, communicate documentation standards, and coordinate assembly of regulatory dossiers.
- May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
- May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
- A relevant technical diploma.
- 2 years experience in a related environment.
- Strong attention to detail,
- Good organisation, flexibility and adaptability skills would be an advantage for this role.
- Family health insurance,
- Excellent pension scheme
- Life assurance
- Career Development
- Fantastic new facility
- Growing business plus access to many more benefits.
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Documentation Control Specialist - Kilkenny, Ireland - Abbott
Description
Have you ever wanted to make a difference?
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
Abbott Ireland
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Diabetes Care Kilkenny
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
This is how you can make a difference at Abbott:
As Document Control Specialist you will ensure a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
Responsibilities
Qualifications and Experience
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
Abbott is an equal opportunities employer.
