The main responsibility of this role is to ensure the timely and correct progression of change control for selected products at different stages (e.g. API, DS, DP and FG) and across modalities (i.e. LS, SM, Biosimilars etc.). In addition, this role provides quality support for the manufacture of products, ensure documentation management (periodic review of procedures, ad-hoc update of procedures etc.) and process improvement, collect and perform trend analysis based on indicators as well as feedback from other departments and prepare, draft sections of Annual Product Review Reports of selected products. In field of deviation, complaints & CAPA, this role ensures the timely and appropriate investigation, impact assessment, close out with involving partners and contractors.
Global External Quality Associate
- area of Zug
Within the Pharmaceutical Industry globally & successfully operating company.
area of Zug
as soon as possible
A dynamic, multi-cultural working environment focusing on transforming discovery into care combine with attractive career opportunities and competitive compensation & benefits.
Bachelor's degree, Master's degree preferred in related topic Pharmacy, Chemistry, Biology, Biochemistry etc.
You bring at least 2 years of experience in a similar position within pharmaceutical/biotechnology industry and hands-on expertise in change control management preferably in Finished Goods (FG) with you. Further, you gained already knowledge in either manufacturing, development, quality or regulatory. Good understanding of cGXP's, quality systems and regulations such as FDA and EU, others are a big plus. If you have already gained knowledge of medical device regulations and manufacturing, as well as of IT Systems Oracle Aigle or Trackwise it is of an advantage. In addition, organization and communication skills belongs to your strengths and you are able to work with MS Office on a daily basis. If you are interested, please directly send your application to firstname.lastname@example.org
Englisch: Very good
This position is offered as a six-month contract, with a strong option to get extended. Client Ref. Nr. BIOBJP00002526, please integrate into your application.