Audit & Supplier Management Specialist

Reporting to the Senior Manager of Audit/Inspections and Supplier Management ; The Audit & Supplier Management Specialist is responsible for all aspects of audit, inspection and supplier management activities.Under minimal supervision, responsible for:GMP/GxP audits of vendors and internal sites and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites. Also responsible for supporting inspection preparations for Health Authority inspections and customer audits.Supporting the quality compliance in all areas/functions of the business to ensure an optimal Supplier Management program (including: Quality Agreements, Change Notifications, Third Party Complaints, Enrolments) is executed successfully. Provides support for the establishment and management of the Quality Supplier Management ProgramMaintain and execute the company’s Quality Supplier Management ProgramAssist in the development of a global Approved Suppliers List in collaboration with other sitesAssist in establishing the strategy, standards, global processes and procedures for supplier and material introduction/enrolment and on-going monitoringManage the establishment and maintenance of Quality Agreements with Third PartiesAssist in managing the development and reporting on supplier quality Key Performance Indicators (KPIs) driving to optimize improved performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or systemManage implementation of supplier change notificationsProvides support for the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirementsSupport to develop quality policies, procedures and standards governing and harmonizing of the global audit and inspection program for all Seqirus sites.Assist in the development of a global audit program and schedule in collaboration with other sites.Ensure that all audits (Contract manufacturers/ Vendors/ distributors/ laboratories/service providers) and inspections are performed as per plan (either internally or by a 3rd party contractor).Stay current and up to date with any new regulations and industry trendsEnsure to upkeep accreditation, qualification to perform required inspections and adhere to processes and SOPs ensure inspectors are trained and accreditedSupport the global model for corporate audits (bi-annually) to identify weakness in cGMP systemsEducation RequirementsBachelor's degree in science or engineering discipline Advanced degree a plusExperience RequirementsMinimum of 5 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred.Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations requiredDemonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teamsMust have experience as a qualified Auditor within a highly regulated industry.Our BenefitsSeqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.About Seqirus Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at Seqirus.Do work that matters at Seqirus!Watch our ‘On the Front Line’ video to learn more about Seqirus

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Posted 2 weeks ago

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