Q.A. Regulatory Affairs Manager
Our client is an international biopharmaceutical drug discovery and development company, headquartered in Dublin currently looking for a Quality Assurance & Regulatory Affairs Manager.
The successful applicant will have responsibility for overseeing quality assurance and regulatory compliance activities including but not limited to QMS Development and SOP management, performing Internal and Vendor audits (GCP, GMP, GLP), document control, deviation and CAPA management.
It is essential the candidate has appropriate experience in an API or a Product manufacturing facility. The position is a full time, permanent position and some audit related travel will be required.
The preferred candidate will have a minimum of 5 years quality assurance / regulatory experience in a pharmaceutical manufacturing or similar environment as well as a relevant Science qualification (degree level at a minimum). Experience working in a CRO would be desirable.
The ideal applicant will need to have a thorough understanding of regulations related to clinical trials and clinical manufacturing and experience with the regulatory submission process. The candidate should have excellent organizational and interpersonal skills and be capable of working independently as well as part of a team.
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