Quality Systems Specialist

Dublin, Dublin West
EUR40000 - EUR50000 per annum + health insurance + 25 days holidays
18 Sep 2019
02 Oct 2019
Quality Systems
Ann Marie Corcoran
Job Type
Quality Systems Specialist

Responsibilities include managing and coordinating the internal audit system, managing change control system, the process of vendor/service provider qualification and other activities related to QMS.
Contribution to the continuous improvement of the Quality Management System is required.

The Role
Management of Documentation Compliance Manager (DCM) system and archiving in relation to QMS systems
Provide reports to site in relation to Quality Management System (QMS) Documentation System as required.
Authoring of Standard Operating Procedures (SOP's) in relation to the Documentation System
Communicate with cross functional departments
Communication with the manufacturing sites in relation to QMS activities where appropriate
Management and coordination of CAPAs
Provide administration support in relation to Annual Product Reports
Management of GMP introductory and annual refresher training for all GWWO employees
Provide support to corporate and health authorities' site audits and response to audits' findings

Excellent communication skills Competence in Microsoft packages specifically Word, Excel and PowerPoint
Ability to work proactively on own initiative
Excellent technical writing and analytical skills
Good organizational and time Management skills
Results orientated
Minimum of 2 years' experience in an Document Control role preferably in a Quality Control/Assurance setting and with experience in using Microsoft packages
Experience in managing/coordinating Change Controls, CAPAs
Degree in a science, pharmacy or related discipline.
Extensive knowledge and understanding of regulatory requirements and guidelines.
Experience in the pharmaceutical or related industry working under quality management systems

Desired Requirements
Experience of working in a team environment and participating in Project teams.
Experience in Documentum
Experience/certification in auditing

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