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CSV Engineer
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| Location: | Cork |
|---|---|
| Tags: | validation | gamp | compliance | risk | software testing | gmp | manufacturing | |
| Type: | Contract |
Our Client a leading Medical Devices company are looking for a CSV Engineer for an immediate start in Cork.
Responsibilities:
+Ensure Regulatory compliance in the area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI)
+Provide guidance and assistance in the execution of software Validation's and software testing ensuring that validations are compliant to Global, Divisional and Local Procedures·
+Review, Approve and assist in the creation of Risk Assessments, URS, FSDS, Software Design Specifications, and CSV Validation protocols·
+Create the Site Validation Master Plan for CSV and maintain as a live plan throughout the site·
+Lead training activity on CSV to current GAMP, ICH, FDA requirements targeting all personnel within Stryker involved in software Validation·
+Ensure regulatory compliance in the area of CSV with respect to GAMP 5, 21 CFR 11 compliancy, FDA, IMB, ICH, BSI regulatory requirements and identify Gaps where present
Skills:
+Minimum if 4 years experience in a CSV role within a manufacturing company.·
+Excellent knowledge of GAMP 5, ICH Guidelines, 21 CFR 11 Compliancy requirements
http://www.technojobs.co.uk/job.phtml/150756
