HERO Recruitment

Senior Compliance Specialist (BB-F1332)

Found in: Neuvoo IE

Senior Compliance Specialist My client a leading pharmaceutical company in Sligo is looking to hire a Senior Compliance Specialist on a one-year fixed-term contract basis. As the Senior Compliance Specialist, you will be responsible for developing, managing, and documenting Quality Systems to ensures full compliance with all applicable regulatory and requirements. Key Responsibilities include:Coordinate the development and maintenance of the company's quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured meet the requirements of end-users, of regulatory authorities and the companyLead and guide team members including Compliance Specialists, Documentation Controllers and QA Administration ControllersDevelop and coordinate the Quality System, ensuring full compliance by all personnel with its requirementsEnsure Quality Systems Manager and QA Director is kept informed of system failures to ensure corrective/ preventive action is undertaken where requiredTake ownership of performance measurements of the Quality System providing reports at management review, during quality performance meetings and all other required reviewsPreparation of plant Site Master File and Product Quality ReviewsAssisting in the investigation of and coordinating customer complaints/exceptions by ensuring the implementation of effective corrective/preventive action where necessarySupplier evaluation and approval of maintenance and technical agreementsCoordinating and management of change control programs and ensuring compliance reviews on change requests are performed on non-manufacturing related changesSupport the Quality Systems Manager and QA Director in Inspection readiness programsWork closely with the International Quality Assurance, FDA, IMB and other regulatory bodiesEstablishing the Corrective / Preventive Action system and proceduresVerification of effectiveness of corrective/preventive actions arising out of product, vendor evaluation and approvalWorking with QA Director, Compliance and MQA group to ensure we meet the customer, quality, service, regulatory and financial goalsIdentifying any causes of non-compliance of the quality system while maintaining effective communication with all employees within the plant and external auditorsAdhere to and supports all EHS & E standards, procedures, and policiesEducation and experience required: A third level qualification in a science, quality or relevant disciplineAt least 4 years' experience in a similar positionStrong knowledge of regulatory requirementsQuality systems experience and familiar with vendor evaluation, qualification, coordination of change management process etc.Strong communication skills both verbal and writtenFor further information on this Senior Compliance Specialist role in Galway please contact Clara Burke on (phone number removed) / Check out all our open jobs on our HERO Recruitment website - Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

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