Compliance Coordinator

ProClinical Limited
03 Oct 2017
02 Nov 2017
Contract Type
Full Time
A well-known international pharmaceutical company with sites around the globe is looking to hire a Compliance Coordinator. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. The Compliance Coordinator reports to the Europe Regional Lead, Lifecycle and Growth or designee, working under close supervision and is committed to quality and excellence in compliance and conformance. Job Responsibilities: * Ensures timely communication of any issues. * Work in close collaboration across the regulatory organization between Global, Regional and Country teams. * In support of Post Approval CMC submissions for MRP/DCP/CP Licenses, ensure compliance systems fully reflect HA status * Maintain systems and databases per internal SOPs and policies * Operate to the highest conformance standards * Operate in line with internal SOPs and policies * Liaise with regulatory colleagues to communicate and resolve potential issues Skills and Requirements: * Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science. * Experience in a quality or compliance role within the pharmaceutical industry - minimum 2 years of experience. * Strong compliance focus and understanding * Good knowledge of content and requirements for CTD Module 3 * Attention to detail * Demonstrated experience with a pharmaceutical company with proven examples of contribution. * Knowledge and understanding of quality systems, processes, audit and inspection * Experience with maintaining electronic systems and databases * Maintain systems and databases per internal SOPs and policies * Knowledge on general standards, processes and policies of Pharmaceutical Manufacturing Industry * Good communication and interpersonal skills * Team player To Apply: Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on [Phone number removed] or upload your CV on our website - [URL removed] A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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