This job is currently Archived,
Posted on : 10 July 2017
Location Galway - IrelandDepartment Name Quality Assurance/Regulatory Affairs (QA/RA)Functional areaQA/RAReports ToQA/RA DirectorJob SummaryManage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.Duties / ResponsibilitiesCoordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.Lead preparation and coordination activities for external audits and liaise as required with SME s to ensure audits are conducted in an efficient manner.Co-ordinate the Document Control Function in conjunction with the appropriate resources.Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.Promotes the awareness of regulatory and customer requirements throughout the organization.Supports Quality training on site.Methodical review approach and be capable of initiating and leading change and continuous improvementSpecific RequirementsAbility to work within a team environment to achieve agreed company goals.Ability to communicate quality / regulatory concepts effectively.Excellent understanding of ISO 13485 and FDA QS regulations.Formal Audit TrainingProficiency in use of desktop software applications such as MS office.Some travel may be required with the role.Education / ExperienceA degree in Engineering, Technology, or ScienceAt least 3-5 years experience working in a regulated medical device or pharmaceutical company.Excellent planning and coordination skills.Excellent verbal and written communication skills.Excellent attention to detail skillsClosing Date for ApplicationClosing Date 12th July 2017 Aerogen is the world s leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems.
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