Beschreibung
Quality Assurance SpecialistDuration: to months)
Location: Zug
Main Responsibilities:
Manage the QA interface with manufacturing and testing partners for commercial biosimilar finished products by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.
The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, as well as the organization and conduct of quality management reviews with contract manufacturing organizations.
The role also includes quality management of the product lifecycle management in relation with contract manufacturing and support to CMC functions such as review and approval of regulatory filings.
Education and background needed:
- Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries
- Relevant experience in either manufacturing, development, quality or regulatory;
- Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus);
- Knowledge of medical device regulations and manufacturing is a plus.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.