QA Specialist - IVD - cGMP - ISO 13485 - £32k-£35k - Kent
QA Specialist - IVD - cGMP - ISO 13485 - £32k-£35k - Kent - Risk Management - CAPA - FDA- QSR 820 - Design Control
A global diagnostics organisation is seeking an experienced QA Specialist to join its Kent facility. You will be an experienced QA professional with expertise in cGMP environments and knowledge of IVD design control and risk management processes. Reporting into the QA Supervisor, you will play a key role in a busy QA department.
Please note that this role has an anticipated start date of January 2017.
1.To review batch records prior to release of Diagnostic/Therapeutic Intermediate/Traded Products and IVDs.
2.Assess the quality impact of any process prior to release of product.
3.To review and approve all documents within the scope of the Quality Management System.
4.To assist in management of the internal audit programme and to conduct regular internal audits to assess compliance to appropriate FDA QSR 820, ISO 13485 and ISO 9001 requirements. To assist in external audits of suppliers as directed.
5.To prepare audit reports and raise non-compliance notices for areas which need improvement.
6.To assist in the management of the internal non-conformance management systems specifically CAPA, Deviations, Supplier Corrective Action Requests & close out of Customer Complaints.
7.To assists in Customer Complaint Handling and Reporting.
8.To perform training on quality issues as and when required.
*Degree level, preferably in Chemistry, Biology, or a related subject
*QA experience preferably from cGMP environment
*Use of Microsoft Word, PowerPoint and Excel
*Knowledge of quality aspects of supplier management desired
*Knowledge of IVD Design Control and Risk Management Processes desired
*Understanding of ISO 9001 and ISO13485 Quality System
Cranleigh Scientific is acting as sole agency in the recruitment of this position. Please direct all applications to Katie Pink - firstname.lastname@example.org
No further information will be disclosed over the phone without a prior application or CV submittal.