On behalf of our client, a global medical devices and medicical products company, we are currently recruiting for a Quality Administrator role. This is a permanent, full-time role based close to Dublin City Centre.
DUTIES AND TASKS:
• Maintaining the internal CAPA/Complaint/SCAR/Non-conformance and Change Control system
• Driving actions to closure, providing status updates to management
• Maintaining the internal and external audit schedule
• Support with supplier approval (Bona Fide) and review
• Support with supplier re-evaluation
• Gathering and organizing findings, issuing reports in preparation for audits
• Gathering data for scheduled meetings (management, manufacture, distributor)
• Provide administrative support for users of the electronic document management system (EDMS)
• Upholding the Document Control and Records Management systems.
• Supporting internal departments, manufactures and distributors during new product introductions and regulatory inspections.
• Maintaining warehouse and logistics inventory reports
• Support Pharmacovigilance as directed when required
• Gather batch release documentation for Quality Manager / Management Rep to review.
• Other ad hoc duties as and when required
Skills & Experience Requirements:
A degree in a life science or pharmacy discipline.
• 2 years’ work experience in a compliance environment and a good understanding and working knowledge of GDP, GMP and ISO 13485
• Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland, EU and US.
• Proficiency in the English language with strong verbal and written communication skills is essential.
• Ability to process technical information.
• Accuracy and excellent attention to detail.
• Excellent organisational skills.
• Good interpersonal skills.
• Computer skills (Microsoft Word, Excel, SAP an advantage)
• Some travel to Italy/Germany may be required once or twice a year
For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail LDunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671