Quality Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
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 114000 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 Ireland Abbott currently employs about 6000 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 atAbbott:
In this role you will be responsible for creating and implementing theAbbottDivisionvalidationprogram. Creating and maintainingvalidationdocumentationfor new and existing systems and processes subject todesign control. You will also ensure thatvalidationactivities are implemented for systems and processes used to manufacture control and store intermediates and finished products to requirements and standards as listed in the currentQuality SystemsManual.
It will be a very big plus if you can bring experience in developing projects or sites from square one.
Key Responsibilities
Thedevelopment and maintenanceof Quality System procedures.
Ensuring the site deliverssafeand effective products that meetcustomer needswhilst maintainingcompliance.
Monitoring and maintaining the quality andcompliancestatus of associated quality records.
Maintaining the quality andcompliancestatus of associated Procedures work instructions and training materials.
Presentingand communicating status reportmetrics identify trendspotentialissues improvementinitiatives as applicable.
The review and approval ofvalidationdocumentationin accordance with divisional policies.
Basic understanding ofdesigncontrols anddesigntransfer.
Qualifications and Experience
Relevant third level qualification.Engineering/Manufacturing/Scienceis preferred.
Minimum 2 years in theEngineering/Manufacturing/ Scientific field.
2-3 years working knowledge of process equipmentfacilitiesand or softwarevalidationeither within Quality orEngineeringdepartments
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.
Connect with us at abbott.com or .abbott/ onLinkedInat linkedin.com/company/abbott-/ onFacebookat facebook.com/Abbottand on Twitter @AbbottNews.
Abbottis anequal opportunitiesemployer.
The base pay for this position is
N/AIn 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
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
