Abbott PQA Specialist in Longford, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Diagnostics Division – Longford (ADDLF)
Abbott established the first diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents. In 2004, Abbott Diagnostics operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004. Manufacturing commenced in March of the following year and the first product (Architect TSH) was launched in December of 2005.
The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.
We currently have a permanent positon for a PQA Specialist (Product Quality Assurance) and this role will involve the following:
The incumbent makes ensures the assigned areas of the Global PQA group is effectively maintained and compliant with the requirements specified in the Division Quality System, the relevant international standard (e.g. ISO) and other applicable standards e.g. IVDD, FDA.
Perform timely Customer Complaint handling including administration, investigation and approval
Generate PQA Metrics
Organise Monthly Complain Reviews with management
Tracking and review of Post Market Surveillance data, highlighting any issues to
Technical and management
Support of Internal and External Audits
Support of the Global PQA Complaint Team with regards to Complaint pulls, Risk Evaluation, Customer Communication
Support Vigilance Requests and any other complaint related request
Support Quality Holds and Quality Communications
Education & Experience
You will have a relevant third Level qualification in a Life Science or Quality discipline with a minimum of 1-2 years’ experience in the support of technical operations, development, testing, manufacturing or quality areas preferably in a regulated environment
Proficient in Microsoft Office (Word, Excel & PowerPoint)
Good communication/team and interpersonal skills are essential for the position.
Strong attention to detail
The ability to work co-operatively and effectively with others to establish and maintain good working relationships
To display the highest levels of integrity in the successful completion of work
Good software and report writing skills
Ability to work on own initiative
Proven problem solving skills are essential
Discover why candidates choose a career at Abbott Ireland here at http://bit.ly/workingatabbottireland
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org