Quality Specialist

Location
Dublin West, Dublin
Salary
EUR40000 - EUR58000 per annum + bonus + 25 days holidays + health ins
Posted
06 Dec 2018
Closes
20 Dec 2018
Ref
Quality Specialist
Contact
Ann Marie Corcoran
Sector
Manufacturing
Job Type
Permanent
Hours
Full-time
Reporting to the Technical Director the Quality Specialist is responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.

Responsibilities include managing and coordinating the Internal audit system , managing Change Control system and other activities related to QMS.
Contribution to the continuous improvement of the Quality Management System is required.

KEY RESPONSIBILITIES

Management of Documentation Compliance Manager (DCM) system
Provide Reports to site in relation to Quality Management System (QMS) Documentation System as required.
Management of Documentation Archive for QMS documentation.
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 Internal audit system
Management and coordination of Change Control system
Management of deviations related to Documentation control
Provide administration support in relation to Annual Product Reports
Contribution to the continuous improvement of the Quality Management System
Management of GMP introductory and annual refresher training for all employees
Provide support to corporate and health authorities' site audits and response to audits' findings
Other duties as required by the Technical Director


KEY COMPETENCIES

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
Flexibility
Results orientated
Qualifications

Degree in a science, pharmacy or related discipline.
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 of working in a team environment and participating in Project teams.

Experience working in distribution/manufacturing supply chain experience in the pharmaceutical or related industry working under quality management systems in an environment of continuous improvement desirable.

Contact Ann Marie Corcoran for more information

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