Abbott Ireland are looking for a Specialist Quality to join the Abbott located in Dublin.
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 10 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, support operations and shared services in Dublin. 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 Medical Optics – Liffey Valley & Westport
Abbott Medical Optics (AMO) is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages.
We do this by providing a Complete Refractive Solution to address vision disorders at all stages of life. We offer market-leading technologies for myopia, hyperopia, astigmatism, contact lens care and corneal health, as well as proven educational and support programmes that help eye care professionals master refractive technologies and grow their practices.
AMO has centralised customer service and finance functions for the Europe, Middle East and Africa (EMEA) region in Ireland and delivers these through two shared services centres, in Liffey Valley, Dublin and Westport, Co. Mayo respectively.
Employees across both offices are in constant contact with customer, suppliers, distributors and AMO colleagues across the EMEA region.
We are looking for a Specialist Quality (12 months contract) to join Abbott located in Dublin Liffey Valley and this role will involve the following:
The Quality Specialist is responsible for providing QA general support for assigned quality systems to meet GMP and other applicable regulatory standards and the appropriate market requirements.
- Manage QA systems as assigned from a Quality perspective.
- Support preparation of Quality/Technical Agreements to align with the legal contracts.
- Support a program/project management process to support quality and compliance initiatives at TPMs.
- Support the management of critical exception documents and CAPA and review with Quality Manager prior to decisions for relevant TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
- Coordinate and support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
- Support the preparation of Product Quality Reports to ensure accuracy, completeness, timeliness, and that trends are identified and addressed in an appropriate manner.
- Support TPM Quality Heads in providing quality and compliance support/advice.
- Provide support for quality audits and initial site approvals.
- Provide technical expertise and hands-on service, utilization of systems and additional Abbott resources to support quality and compliance related activities for QA Contract Operations.
- Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Third Party Manufacturing Quality or Technical Agreements.
Supervisory or managerial responsibility
- Contact with Abbott personnel at many levels, Divisions and Affiliates
- Frequent contact with TPM personnel at all levels
- Continuous contact with Quality Manager and Director and appropriate Workstream Teams.
Education & Job Skills
Degree in a relevant Quality or technical/scientific discipline
- (Experience) Understanding of pharmaceutical manufacturing for finished dosage forms with experience in QA, Operations, or Technical Support in a pharmaceutical setting. Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s. Basic experience in project management and data management tools.
- (Problem Solving) Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives. Capable of analyzing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
- (Accountability) Responsible for ensuring that Quality Systems maintain in compliance with local and International regulations so that GMP decisions can be based on them.
- (Scope of authority) Support the management by providing relevant information for decision making. The position receives supervision through Quality Manager.
Visit Abbott at www.abbott.ie or www.abbott.com and connect with us on LinkedIn at www.linkedin.com/company/abbott