Beschreibung
Labeling Specialist - Regulation/ cross-functional / engineering / regulated environment / germanProject / Role:
For our client Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Labeling Specialist
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 correct labeling, and as a Labeling Specialist, you will have a crucial role in ensuring that our product labels fulfill the requirements of Regulation (EU) (IVDR).
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.
Part of the tasks of this position is specifically acting as an interface for the Labelling Department in Mannheim, therefore language Skills in German and English Language are very important. In addition, the candidate will support the Consumables Departments in all labelling related issues. We are searching for candidates with a proven background in the below related fields (must have criteria), only background in a Pharmaceutical Production role is not fully sufficient.
Tasks & Responsibilities
- Updating the product labels and related documentation to fulfill the Regulation (EU)
- Participating in cross-functional and cross-business Area project teams
Must Haves
- University degrees in Engineering / Life science / or related fields (as example Natural Sciences, Regulatory Affairs, Quality Management) or corresponding working experience in Regulatory Affairs / Labelling or QA
- Basic knowledge of regulatory and normative guidelines (ideally of new EU Regulation )
- Experience in working in a highly regulated environment
- Excellent communication skills in English, good communication skills in German (interaction with Site in Mannheim)
- 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
Reference No.: 919873SGR
Role: Labeling Specialist
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 04.01.2021
Duration: 12++
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 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.