(Sr) Artwork & Masterdata Officer

The (Senior) Artwork & Masterdata Officer is responsible for 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.

Responsibilities

Master data:

• 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 maintenance of production protocols based upon released batch records in the Document Management System (Q-pulse).
• Proactive interaction with internal departments; Regulatory Affairs, Technical Transfer, Sales, Marketing and Research & Development to ensure timely implementation of new product introductions.
• Submission and execution of change controls of the HAL product portfolio under supervision of the Supervisor Artwork Management.
• GxP compliance of master data and master data processes under supervision of the Supervisor Artwork Management.

Pharmaceutical Artwork:

• Ensure compliance of artwork as per style guide requirements (branding, font size, technical layout).
• Submission and execution of 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 including the coordination thereof under supervision of the Supervisor Artwork Management.
• 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.

General:

• Ensure compliance with GDP guidelines for both master data and pharmaceutical artwork.
• Accurate archiving of all GxP documents related to approved artwork and productconfigurations.
• Investigating role in CAPA and Deviations in relation to artwork components or Masterdata.
• Contribution to project team for artwork related business or Masterdata.
• Act as a single point un-blinded team member for the randomization of clinical trials.

Profile

• 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 inmanufacturing.
• 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.

Offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full product pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• A 13th month salary.
• 30 leave days.
• Company contribution to a pension package and heath insurance.

Other information

Your application

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, for those who seek for pharmaceutical innovation.

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!

HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.

Recruitment
recruitment@hal-allergy.com