Beschreibung
Labeling Specalist (f/m/d) - engineering / regulatory affairs / German/ EU) / AdobeProject:
For our client Roche Diagnostics International, based in Rotkreuz, Switzerland, we are looking for a highly qualified Labeling Specalist
Background:
Product labels and labeling are one of the most important forms of documentation that a medical device company can produce as the labeling has a direct impact on the way the customer interacts with the product itself. No product can be sold without a correct labeling, and as a Labeling Specialist you will have a crucial role in ensuring that our product labels fulfill the applicable requirements.
The Product Labeling team is part of the Operations Support at the Roche Diagnostics International (RDI) and is responsible for the labels of all the RDI products. The team manages the product labeling process, creates and approves the individual labels and closely collaborates with the Manufacturing, R&D, Quality and Regulatory Affairs, also at other Roche Diagnostic Sites. The mandate of the team is, to reliably deliver the product labels, put regulatory requirements into practice and continuously improve what it does.
The perfect candidate:
Has a professional background in a life science or engineering related discipline and first experience in labeling, regulatory affairs OR quality assurance.
Tasks & Responsibilities:
* Authoring and approving labeling documentation
* Designing and creating labeling artwork
* Coordinating labeling related topics between the labeling team and the different stakeholders
* Assessing and improving the labeling process
* Leading small projects for label changes or process updates
Must Haves:
* Professional background in life science or engineering
* First experience in regulatory affairs OR labeling OR quality assurance
* High level of motivation and a "can do" attitude. Openness and flexibility to change
* Ability to see the big picture but also an attention to detail when needed
* Good analytical and problem solving skills (
* Understanding of processes and process improvement
* Good team working skills
* Excellent communication skills English, good communication skills in German
Nice to have:
University degree in life science or engineering
* Experience in working in a highly regulated environment
* Experience in label artwork design i.e. in Adobe InDesign or Illustrator
* Basic knowledge of regulatory guidelines, especially Regulation (EU) is an advantage
Reference No.: 921731SGR
Role: Labeling Specalist
Industry: Pharma
Location: Rotkreuz
Workload: 80-100%
Start: asap
Duration: 12++
Deadline: 19.07.2022
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.