Senior labelling officer

Werkgever:
XDES Projects
Regio:
Boxmeer
 
Functieomschrijving

Senior Labelling Officer

  • Quality Assurance, Regulatory Affairs
  • Netherlands, Boxmeer
  • Fulltime
  • V-
  • Competitive

    • The Senior Labeling Officer function its main task is to operate the artwork management process on a daily base. The Senior Labeling Officer trains and guides other Labeling Officers on the artwork management process.
     
    Main tasks:

  • Responsible for guarding the uniformity of country-specific product labeling, achieving deadlines, target dates and internal and external communication.
  • Coordination and implementation of new and revised product labeling in line with regulatory product files.
  • Coordinate small artwork management projects with minimal guidance from the Labeling Coordination. Participates in change teams and can support the Labeling Coordination in PIT teams.
  • Responsible for the correct and timely control of the art-work design department (internal and/or external)
  • Collecting all necessary information for the preparation of new product labeling, such as technical specifications, design specifications, registration requirements and texts.
  • Responsible for proper phasing of the modified materials and control of phasing out of the existing packaging materials.
  • Maintain contacts with all major stakeholder e.g. Local Companies, packaging sites, Regulatory Affairs, Supply Chain Dept., Area Management, external printing, QA.
  • Responsible for correct/complete intake of the documents and procedure that trigger initiation of introductions / changes
  • Responsible for the daily planning of the operational tasks of the labeling team
  • Labeling Officer can have a specialized role to service the artwork management process (examples: business expertise, international packaging role).
  • Is Subject Matter Expert for more than one topic within the artwork management discipline (e.g. pack site, global topic on downstream artwork management processing, work process, business expertise).


    • Job requirements

  • Bachelor degree is required or proven related working experience
  • Preferably gained work experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry.
  • Preferably experience working with an artwork/document management system
  • Preferably experience with GMP guidelines within the pharmaceutical industry.
  • Preferably have experience of minimally 1 year in coordination within a global initiative/personal
  • Good communication skills
  • Team Player
  • Fluent English (speaking, reading and writing)
  • Service minded
  • Accurate and efficient
     Kernwoorden