Master Data & Artwork Specialist Full-time Leiden
Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Master Data & Artwork Specialist.
About the role:
The Master Data & Artwork Specialist implements and maintains both product and artwork configuration in several quality controlled systems (e.g. SAP, Master Control), including the operational management of 3rd parties involved in the creation thereof.
You ensure that current and future products of Pharming (manufactured and/or sold) can be produced and distributed following the GxP guidelines, with the goal to improve quality of live of patients.
Areas of responsibilities:
Ensuring GxP integrity and quality of master data in key systems (SAP, Master Control) as well as maintaining the processes to support the data quality, and documentation of these processes (if necessary, with other functional data owners);
Based on defined release and decommissioning processes in the key systems setup, maintain and decommission, inter alia, item master data, location master data, including machine and work center data, bill of resources, bill of materials, bill of sampling, customers including price lists and suppliers including outline agreements;
Assisting in the application and implementation of procedures for data standards and guidelines on data ownership, coding structures, and data replication to ensure access to and integrity of data sets;
Artwork
Manage the creation of and maintain the process for artwork development for printed packaging components from specification through publishing to external suppliers for artwork globally
Ensure appropriate approvals are obtained from other functions where applicable, assure communication is made with third party manufacturer/packager and all necessary proofreading are completed at all stages as per current procedure
Responsible and accountable for process execution and adherence to required completion date.
Document, submit, monitor the execution of, and closure of change controls related to phasing in and phasing out of, inter alia, markets, dossier changes, products, locations, customers, suppliers, work & machine centers etc;
Interaction
Setup and maintain proactive interaction with all internal departments (i.e. Clinical, finance, manufacturing, marketing, procurement, quality assurance, quality control, research & development, regulatory affairs, and sales) involved in the creation and decommissioning of master data and its related artwork.
Act as SME for end user support and training
Participates in cross-departmental projects
Required skills and qualifications in order to be successful in this role:
Accuracy;
Planning and organizing;
Independence;
Customer orientation (internal and external);
Results orientation;
Organizational sensitivity ;
Problem analysis;
Teamwork.
Knowledge:
MBO degree with preferably HBO level of thinking;
Good X Practice (GxP) knowledge of Manufacturing, Distribution, Documentation, Clinical;
ERP systems (preferably SAP);
Excel knowledge;
Pharmaceutical packaging & artwork;
Industry standards and regulations in this domain
Text verification tools;
Project / time management skills;
Good analytical and problem-solving skills;
Working knowledge of the Dutch and English Language, other languages are beneficial.
Experience:
7+ years’ experience in data management and (pharmaceutical) artwork management