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