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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Abbott Diabetes Care Kilkenny
Abbott Diabetes Care has opened a new site, in Kilkenny, that is at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.
This is how you can make a difference at Abbott:
In this role you will be responsible for creating and implementing the Abbott Division validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.
It will be a very big plus if you can bring experience in developing projects or sites from square one.
Key Responsibilities
* The development and maintenance of Quality System procedures.
* Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.
* Monitoring and maintaining the quality and compliance status of associated quality records.
* Maintaining the quality and compliance status of associated Procedures, work instructions and training materials.
* Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.
* The review and approval of validation documentation in accordance with divisional policies.
* Basic understanding of design controls and design transfer.
Qualifications and Experience
* Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
* Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
* 2-3 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
* Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
* 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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Abbott is an equal opportunities employer.
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:
ADC Diabetes Care
LOCATION:
Ireland > Kilkenny : Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Ie - Kkyflx (Ireland)
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable