interims Quality Specialist - Release & Review
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Baden-Württemberg Germany.
My client, a leading name in the pharmaceutical industry, is currently looking for a Quality Specialist focussing in the fields of IMP release and batch review. The position is located in the greater Ulm area, where the company produces biopharmaceuticals, and is to be filled immediately for the duration of 6 month (with an option of extension).
ROLE DESCRIPTION
As Quality Specialist you're mainly responsible reviewing the IMP release files as well as batch documentation to ensure compliance according GMP. You'll work closely with the local QP and report to him directly.
RESPONSIBILITIES
Review of IMP release files to ensure compliance according cGMP
Review of GMP batch documentation as well as responsibility for assigning and documenting the batch status
Perform and document the review of IMP release files according regulatory compliance and cGMP compliance
Conduct and review relevant SOPs
Assuring the correct batch status for finished, semi-finished and bulk product
REQUIREMENTS
University degree in a natural science, e.g. Chemistry or Biology
Multiple years relevant work experience within a pharmaceutical manufacturing environment
Several years experience with Quality Systems as well as knowledge of quality and regulatory requirements
Knowledge of IMPs & Clinical trials as well as knowledge of cGMPs/GMP processes and of national legislations like AMG or AMWHV
Very good German and English language skills (orally & written)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.
