Packaging Change Specialist
4 weeks ago
Position SummaryKey SME for the Alexion artwork management system, including day to day management, metric reporting and training of users.Maintains approved packaging artworks and designs (outer cartons, labels and leaflets) and owns implementation of changes including obtaining final approvals from Regulatory Affairs & Quality Assurance.Maintain a line of sight for all printed packaging change for Alexionand ensure implementation deadline are consistently met.Responsible for the maintenance of finished product and material specifications.Global Supply Chain Artwork representative for new product launches.Maintain strong working relationships with contract packaging firms and internal partners to insure product launches and required changes are implemented per established timelines and all distributed product are compliant with filed dossiers.Support implementation of Artwork related projects to maintain and improve productivity and service provided by Global Supply Chain.Manage the artwork process relationship with global, regional and local regulatory affairs functions.SME and process management for Alexion's printed packaging security features.Identify continuous improvement opportunities using structured problem solving methodology.Job Duties & ResponsibilitiesMaintains approved packaging artworks and designs (outer cartons, labels and leaflets) and owns implementation of changes including obtaining final approvals from Regulatory Affairs & Quality Assurance.Maintain a line of sight for all printed packaging change for Alexion and ensure implementation deadline are consistently met.Responsible for the maintenance of finished product and materialspecifications.Global Supply Chain Artwork representative for new product launches.Maintain strong working relationships with contract packaging firms and internal partners to insure product launches and required changes are implemented per established timelines and all distributed product are compliant with filed dossiers.Support implementation of Artwork related projects to maintain and improve productivity and service provided by Global Supply Chain.Manage the artwork process relationship with global, regional and local regulatory affairs functions.SME and process management for Alexion's printed packaging security featuresIdentify continuous improvement opportunities using structured problem solving methodology.Essential QualificationsAt least 5 years user-experience in the development and improvement of artwork management process and systems.Solid understanding of Pharmaceutical Artwork process and associated systems, experience of this function within a Pharmaceutical packaging environment is required, experience withMedical Device packaging requirements is also an advantage.Proven track record in the successful management of pharmaceutical artwork in compliance with regulatory requirements.Strong understanding of current pharmaceutical packaging regulations and application.Experience with management of pharmaceutical product artwork across multiple regions.Strong understanding of cGMPs.Must have excellent computer skills with experience in Artwork Management Systems, experience in SAP highly desirable.Excellent interpersonal and communication skills, with the ability to interact globally and at different levels within the organisation.Preferred QualificationsRelevant 3rd level supply chain qualification.Experience with GLAMs and Gazelle softwareDate Posted06-Oct-****Closing Date05-Nov-****Our mission is to build an inclusive and equitable environment.We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.We welcome and consider applications from all qualified candidates, regardless of characteristics.We offer reasonable adjustments/accommodations to help all candidates to perform at their best.If you have a need for any adjustments/accommodations, please complete the section in the application form.#J-*****-Ljbffr
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