External Manufacture Print Coordinator
3 weken geleden
Job Description
Join our team in Haarlem as an External Manufacturing Artwork Print Coordinator and play a vital role in delivering top-notch artworks for the benefit of patients.
Our Team
Our External Manufacturing (ExM) Artwork Team, comprised of 7 talented individuals, oversees the management of Global Artwork Processes. We ensure consistent deployment of these processes across all stakeholders involved in artwork production. Embracing the GLAMS (Global Label Artwork Management System) business process and interfacing with the SAP system are key to facilitating efficient and compliant artwork change control at our ExM packaging sites.
Aside from managing artwork processes, we extend support for cross-divisional Artwork processes within ExM. Collaboration with Regulatory Affairs, Contract Manufacturing Operations (CMO), Global Technology (ExM GTO), and External Quality Organization (EQA) is essential to ensure alignment of artwork processes with company standards.
Purpose of the role
As an External Manufacturing Artwork Print Coordinator, you will be tasked with overseeing and supporting the development and change control process of artworks within an Artwork Management System (AMS) environment. Post approval of the artwork, you will ensure its correct implementation at our external partners. Collaboration with various departments such as Regulatory, Quality, Supply Chain, and External Manufacturing (ExM) Operations, along with external partner CMO Print Coordinators and CMO Packaging Engineers, will drive an effective and compliant artwork process that is efficient, clear, and user-friendly for all stakeholders.
Our product packaging serves as a crucial conduit for conveying vital medical and product information through cartons, leaflets, and labels. Given that many of our products are packaged by external partners or contract manufacturing organizations (CMOs), ensuring these partners use the most up-to-date product artwork is paramount to benefiting our patients.
To excel in this role, a solid grasp of technical aspects related to packaging sites, coupled with knowledge of quality and compliance standards and the supply chain, is imperative. These three facets are intricately linked with artwork production.
Main responsibilities:
- Assisting or leading coordination and communication on matters concerning the artwork process with external partners.
- Providing crucial support to Supply Chain Planners and Operations Managers to ensure timely implementation of artwork versions as per Regulatory Implementation requirements.
- Collaborating with stakeholders to ensure external partners are ready for new product introductions or transfers, addressing and resolving technical and implementation issues related to the artwork process.
- Tracking and monitoring operational and quality performance of external partners concerning the artwork process.
- Offering proactive support through training and coaching to drive improvements within the artwork process at the contract manufacturing organization (CMO).
- Expanding knowledge on artwork management, remaining abreast of technical trends in line with developments within the company and the industry.
- Working with internal and external teams to prepare external partners for the implementation of key strategic projects, proactively addressing technical and compliance issues to prevent market compliance or stock out scenarios. Examples of strategic projects include serialization, anti-counterfeiting features, new product introductions, name changes, and more.
Your profile
- Bachelor's degree, preferably in: Sciences, Technology, Pharmacy, Engineering (or equivalent);
- Fluency in English, both spoken and written;
- Competent in problem-solving and risk analysis capabilities. Strong compliance mindset, demonstrated interpersonal skills including leadership, coaching, motivation, communication, and negotiation;
- Exhibits organizational skills, is proactive, self-motivated with the ability to multi-task;
- Experience in the pharmaceutical industry or product packaging, Quality Assurance, Regulatory Affairs, and Supply Chain including solid knowledge of global GMP and regulatory requirements is preferred
What we offer
Embark on a journey within a truly global, dynamic, and challenging environment offering abundant opportunities for personal development. Our benefits are highly competitive, and the summary below provides insight into what you can look forward to.
- Competitive salary and a 3% year-end allowance;
- 35.5 days of leave;
- Attractive collective health care insurance package with substantial reduction rates;
- Solid Pension Plan;
- Annual bonus based on individual and company performance
- Company fitness program;
- Travel allowance for commuting;
- Diverse training, coaching, and e-learning modules for long-term job opportunities and growth.
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External Manufacture Print Coordinator
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