(Sr) Masterdata Officer & Artwork

As Master Data Officer & Artwork you are challenged with the implementation and maintenance of both product and artwork configurations in several quality controlled systems (e.g. Navision, Q-pulse, Bar connect and Nice label) in order to make sure medicinal products are manufactured in a compliant manner. You challenge departments and teams to ensure timely implementation of new product introductions and join them in improving the efficiency of the implementation of new product introductions.

Furthermore you:

• Are responsible for the setup, maintenance and decommissioning of all HAL, CMO and clinical item master data based on a predefined release and decommissioning process in all GxP Navision databases.
• Setup and maintain production protocols based upon released batch records in the Document Management System (Q-pulse).
• Proactively interact with internal departments; Regulatory Affairs, Technical Transfer, Sales, Marketing and Research & Development to ensure timely implementation of new product introductions.
• Submit and execute change controls of the HAL product portfolio and you are responsible for GxP compliance of master data and master data processes under supervision of the Supervisor Artwork Management.

Pharmaceutical Artwork:

To make the role even more interesting, you will also have a part in ensuring compliance of artwork as per style guide requirements (branding, font size, technical layout). You actively submit and execute change controls for the implementation of amended artwork and new product introductions of the HAL product portfolio under supervision of the Supervisor Artwork Management. Maintenance and implementation of new or amended, internally or externally printed components is also part of your scope.

Furthermore you:

• Are responsible for the setup and maintenance of label frames in Barconnect and Nicelabel based upon Q-Pulse.
• Responsible and accountable for correct graphical design, obtaining Local Regulatory Affair’s (RAL) and Text Verification Tool (TVT) artwork approvals prior to implementation thereof.
• Planning and coordination of the line clearance process in case of the implementation of updated pharmaceutical artwork components.
• Ensure compliance with GDP guidelines for both master data and pharmaceutical artwork.
• Accurate archiving of all GxP documents related to approved artwork and product
  configurations.

What makes this role interesting?

The focus is on Master data but you will also have the variation of Artwork in your work. You have an investigating role in CAPA and Deviations in relation to artwork components or Master data and you can actively contribution to project team for artwork related business or Master data. Next to this you are a single point un-blinded team member for the randomization of clinical trials.

• MBO/HBO education in administration or equivalent.
• 2-4 years of experience in pharmaceutical, chemical or food manufacturing.
• Solid understanding of ERP systems (preferably Navision with regard to Master Data).
• Solid understanding of the implementation and maintenance of artwork used in
  manufacturing.
• Knowledge of quality records including change controls, CAPA’s and deviations.
• Knowledge of supply chain and inventory management processes.
• Good communication skills in Dutch and English, both verbal and written.

You have keen eye for detail and like to work in a dedicated team of professionals. You actively seek cooperation with you colleagues, are result orientated and you have a good sense of humor.

We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient’s well-being is always top of mind. At HAL Allergy, we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become part of an innovative and challenging pharmaceutical manufacturer, then this is a perfect opportunity!