A Quality Systems Specialist for fixed term contract is required by CareerWise Recruitment for the Global External Supply Division of a Pharmaceutical company based in Dublin.
A Quality Systems Specialist for fixed term contract is required by CareerWise Recruitment for the Global External Supply Division of a Pharmaceutical company based in Dublin. This is an excellent opportunity to join a growing and highly acquisitive biopharmaceutical company at start-up phase of its operations here in Dublin. The successful applicant can expect a varied and challenging role in a fast paced international environment.
* Assist with maintenance of the Document Management System
* Responsible for drafting and reviewing SOP's, Forms, Specifications required to support GxP requirements
* Act in a super user capacity for electronic elements of the Quality Management Systems to assist local users (e.g. Trackwise)
* Support training activities including development and maintenance of training matrices, training folders, delivery of training
* Liaise with the corporate quality functions as required
* Act as owner or QA reviewer for internal deviations, CAPA and Change Controls
* Assist with supplier qualification activities ensuring Approved Supplier Lists are maintained
* Lead or participate in internal /supplier audits
* Assist with integration of new business lines into Quality System
* Assist with preparation and execution of back room activities for Regulatory / Notified Body Inspections
* Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Management Reviews)
* Support maintenance of Licenses including Manufacturing license and Wholesale Distribution Authorisation
* Support monthly reporting of metrics associated with the Quality Management System
* Accountable for completing activities within required timelines
* Proactively highlight any issues around compliance.
* Bachelor's Degree in scientific discipline preferred plus 3-5 years' experience working as a QA Specialist or Quality System specialist
* Direct experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
* Trackwise experience is advantageous
* Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
* Must be able to function effectively in a teamwork environment.
* The incumbent should possess knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485 would be advantageous.
* The individual in this position is expected to represent Mallinckrodt interests, objectives and policies in a professional and responsible manner.
* The individual must demonstrate an ability to work independently.
Please call Pat O'Loughlin today for further information on 01-9108994 or email:
CareerWise Recruitment (In Search of Excellence)
CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors.
Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.
Supporting Business Demands & Growth since 1999
CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.
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