Regulatory Affairs Labeling Officer

  • Brabant
  • 3000.00 - 3500.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Client

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world. Their reputation is based on forming successful partnerships with clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.

Requirements

  • Bachelor degree in a relevant area.
  • Working experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry.
  • Preferably experience working with an artwork/document management system
  • Experience with GMP guidelines within the pharmaceutical industry.
  • Preferably have experience of minimally 1 year in coordination.
  • Good communication skills.
  • Team Player.
  • Fluent English (speaking, reading and writing).
  • Service minded.
  • Accurate and efficient.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Operate the artwork management process on a daily base and train and guide other Labeling Officers on the artwork management process.
  • 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.
  • 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

TAGCLOUD

artwork
#GMP
#pharma
#labeling
#regulatory
#quality
#QA
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1619)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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