Beschreibung
Labeling Specialist (m/f) - regulatory guidelines/ experience in working in a highly regulated environment / German / EnglishRole:
For our client in the Pharma industry based in Region Zug we are looking for a Labeling Specialist, with knowledge of regulatory guidelines.
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.
Areas of responsibility:
- Updating the product labels and related documentation to fulfill the Regulation (EU)
- Assessing and improving the labeling process
- Participating in cross-functional and cross-business Area project teams
Professional, technical and personal requirements:
- University degrees in Engineering / Pharma / Life science / or related fields
- Experienced in writing text of regulatory topics
- Basic knowledge of regulatory guidelines
- Experience in working in a highly regulated environment
- Excellent communication skills English, good communication skills in German
- 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
Nice to Haves:
- Regulation (EU) is an advantage
Reference no: 919355
Role: Labeling Specialist
Industry: Pharma Industry
Workload: 100%
Location: Region Zug, Switzerland
Launch: August/September 2020
Duration: until 31.12.2020, with possible extension
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.