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  • 8 Eastgate Avenue, Eastgate
  • CORK
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  • Job reference number:15321307
  • Client ID:RI/PEJH-3558MYYY
  • Posted on:09-FEB-2018
  • Location:CORK
  • Job type:CONTRACT

Position Description and Responsibilities:

* Supporting the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations.

* Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process / product introductions.

* Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.

* Implement company policies and procedures.

* Work with the various departments / groups in development and execution of validation activities associated with new equipment / product or IM System upgrades.

* Run / Manage complaint investigation and resolution of same.

* Design and develop validation documentation to support business continuity, new process introductions...

* Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation.

* All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.

3/5 years in a Quality function within the Medical Device / Pharmaceutical industry.

Good knowledge of statistical techniques in the use of problem solving / data analysis.

Proven track record in development / execution of Validation programs in areas of Equipment, Process Information management.

Ability to demonstrate standards of leadership - managing complexity / Credo values / Innovations. Customer Focus Flexible Team Player Good influencing skills Project Management skills.

Good Communications skills Methodical Preference will be given to candidates who are very familiar with the relevant regulatory standards (FDA - Quality System reulations, IS13485) applicable to the manufacture of Class 111 medical devices to Global Markets.

Responsibilities and accountabilities will vary for all positions.

Adherence to company procedures is also a responsibility for this role.

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