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Quality Administrator

Reference:SCA007213
Location: Dublin
Qualification:Degree
Experience:2-3 Years
Job Type:Permanent
Salary:Not Disclosed
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Quality Administrator
Our Dublin based client, a specialty pharmaceutical organization, are currently recruiting for a Quality Administrator to join their team on a permanent basis. The ideal candidate will have a life science degree with 2 years experience a compliance environment and a good understanding and working knowledge of GDP, GMP and ISO 13485. As Quality Administrator you will report directly in to the Quality Manager.

Responsibilites
• 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

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)


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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