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External Manufacture Print Coordinator
1 maand geleden
Join our team In Haarlem as an _**_External Manufacturing Artwork Print Coordinator_**_ and contribute to our mission of delivering high-quality artworks for the benefit of our patients._
**Our Team**
Our External Manufacturing (ExM) Artwork Team consists of 7 employees who are responsible for managing the Global Artwork Processes. We ensure that these processes are consistently deployed across all stakeholders involved in artwork production. We adhere to the business process of GLAMS (Global Label Artwork Management System) and interface with the SAP system, which plays a crucial role in enabling efficient and compliant artwork change control at our ExM packaging sites.
In addition to managing artwork processes, our team provides support for the cross-divisional Artwork process within ExM. We collaborate with Regulatory Affairs, Contract Manufacturing Operations (CMO), Global Technology (ExM GTO), and External Quality Organization (EQA) to ensure that the artwork processes align with the company’s standards.
**Purpose of the role**
As an External Manufacturing Artwork Print Coordinator you will be responsible for managing and supporting the development and change control process of artworks within an Artwork Management System (AMS) environment. Once the artwork is approved, you will ensure its correct implementation at our external partners. You will collaborate with various departments, including Regulatory, Quality, Supply Chain, and External Manufacturing (ExM) Operations, as well as external partner CMO Print Coordinators and CMO Packaging Engineers. Together, we will drive an effective and compliant artwork process that is efficient, clear, and user-friendly for all stakeholders.
Our product packaging plays a crucial role in providing important medical and product information through cartons, leaflets, and labels. Since many of our products are packaged by external partners or contract manufacturing organizations (CMOs), it is essential for these partners to use the most up-to-date product artwork to benefit our patients.
To succeed in this role, you should have a good understanding of technical aspects related to packaging sites, as well as knowledge of quality and compliance standards and the supply chain. These three areas are closely interconnected with artwork production.
**Main responsibilities**:
- Assisting or leading coordination and communication on matters related to the artwork process with external partners.
- Providing key 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 that our external partners are prepared for new product introductions or transfers, working closely with internal and external business and operations areas and to discuss and resolve technical and implementation issues related to the artwork process.
- Tracking and monitoring the operational and quality performance of our external partners in relation to the artwork process.
- Providing proactive support in training and coaching to initiate improvements within the artwork process at the contract manufacturing organization (CMO).
- Acquiring and increasing knowledge regarding artwork management, staying updated on technical trends in line with developments within our company and the industry.
- Working with internal and external teams to ensure that our external partners are prepared for the implementation of key strategic projects, promptly addressing technical and compliance issues to prevent compliance or stock out situations in the market. 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 and coaching, motivation, communication and negotiation;
- Demonstrates organizational skills, is proactive and self-motivated with 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**
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
- Competitive salary and a 3% year-end allowance;
- 35,5 days of leave;
- Attractive collective health care insurance package with considerable reduction rates;
- Solid Pension Plan;
- Annual bonus based on own and company performance
- Company fitness;
- Travel allowance for commuting;
- Numerous
