For our customer Molecular Partners AG, a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 160 highly qualified employees we are looking for a
Quality Assurance Specialist - 60% (m/f)
- Management of transfer, implementation and qualification/validation of analytical methods for DS/DP testing
- Development and justification of IPC and DS/DP release and stability specifications, and monitoring of DS/DP release activities at GMP vendors
- Design of DS/DP stability studies under GMP, monitoring of these studies at the GMP vendor and definition/justification of batch shelf life
- Review, assurance of regulatory compliance and approval of GMP documentation
- Evaluation and management of analytical CROs
- Compilation of IMPDs and IND quality dossiers and associated documents, management of review process and preparation of answers to authority replies on IMP quality
- Support of clinical trial submissions, including compilation of quality sections of IBs and Clinical Protocols
- Academic degree in Life Sciences
- 2-3 years of professional experience in Quality Control of protein therapeutics in a pharmaceutical or biotechnology company
- Continuous training in protein analytics, Quality Control and CMC regulatory compliance
- Several years of managing experience of CMOs/CROs and other external partners
- Good knowledge of GMP and applicable regulatory guidelines
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 76 471 68 09).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.