Job Details: Senior Validation Manager

Jervis Street
Dublin 1
Senior Validation Manager

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 **Apply on the website**,**Apply on the website**
colleagues serve people in more than **Apply on the website**

Abbott serves the Irish market with a diverse range of healthcare
products including diagnostics, medical devices and nutritionals
products. In Ireland, Abbott employs over 4,**Apply on the website**
people across nine sites. We have six manufacturing facilities located
in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party
manufacturing management operation in Sligo. Abbott has commercial,
support operations and shared services in Dublin and Galway. We have
been operating in Ireland since **Apply on the website**


Abbott Diagnostic&#**Apply on the website**;s is a global leader of in
vitro diagnostics with approximately **Apply on the website**,**Apply
on the website** institutional customers in more than **Apply on the
website** countries. Our diagnostic products offer a broad range of
innovative instrument systems and tests for hospitals, reference labs,
blood banks, physician offices and clinics.Abbott’s diagnostic
products offer customers automation, convenience, cost effectiveness
and flexibility. Abbott has helped transform the practice of medical
diagnosis from an art to a science, helping to create the modern
diagnostics industry through the company&#**Apply on the website**;s
commitment to improving patient care and lowering overall costs. The
history of Abbott

Diagnostics is filled with examples of first-of-a-kind products and
significant technological advancements.


The incumbent will be responsible as Process Owner for the Validation
Process within the ICHP (Immunoassay, Clinical Chemistry, Haematology
and Professional Services) areas. This process is a cross Division
Process and ownership is shared with the ATM (Abbott Transfusion
Medicine) Validation Process Owner. The responsibilities of the roles
are to manage and oversee the process to ensure compliance with the
relevant regulatory requirements. This position is a Divisional role
and reports to the Quality Director, ADD Sligo.

* Key Quality and Manufacturing Process Owners are responsible for
the oversight and continuous improvement of their process globally.
* Act as the Document Owner and can act as Document SME for all
global documents associated with the process (e.g. Process-level
documents and Learning materials)
* Perform periodic review as defined in Operating Procedure Q**Apply
on the website**.**Apply on the website**.**Apply on the website**
* Ensure that the process remains current, complete, and compliant
with Abbott Policy documents and external regulatory requirements as
defined in Operating Procedure Q**Apply on the website**.**Apply on
the website**.**Apply on the website**
* Review all proposed changes as appropriate with the Process
* Assemble PO/PC Metrics per internal Form **Apply on the website**
requirements for Management Reviews
* Oversight of global investigations and associated
corrective/preventive actions
* Analyse Tracking and Trending of Nonconformances that have
exceeded control limits
* Provide support for Nonconformance and Corrective and Preventive
Action (CAPA) process as defined in Operating Procedure Q**Apply on
the website**.**Apply on the website**.**Apply on the website**
* Identify potential Quality Plan projects
* Assess documents and Learning Materials for process improvements
* Lead process improvement projects
* Establish annual goals and strategic direction of the Validation
Process Community
* Ensure open channels of communication and alignment on approach
with ATM Validation Process Owner
* Ensure Environmental Health & Safety standards are met and all EHS
regulations and procedures are adhered to.
* This position does not have any permanent direct reports but may
be required to supervise individuals or teams on an as needed basis.
* Elevate any areas of potential risk as appropriate mapping out
options, risks and recommended path forward
* Complete a monthly summary and detailed report for area of
responsibility covering achievements, updates, risks.

* Bachelor’s degree preferably in technical/scientific/engineering
* Minimum 5 years’ experience in Quality or Technical role
preferably in Management/Supervisory role
* Minimum 5 years Medical Device Industry experience in validation
* Validation SME knowledge
* Results driven with a collaborative style and positive attitude
* Experience of working in a matrix organisation and liaising with
cross-functional teams
* Excellent communication and interpersonal skills with an ability
to effectively manage all stakeholders, including effective conflict
* Proven track record of proactively seeking feedback and driving
continuous improvement
* Demonstrated experience of effective decision skills

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We need : English (Good)

Type: Permanent
Category: Others

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