Expert Vendor Qualification (7087)

ppCTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed. /p pOur client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases. /p pFor their site in Bern, Switzerland, our client is current looking for a: /p h3Expert Vendor Qualification /h3 pon a 6-month contract, with possibilities of extension. /p h3Main responsibilities: /h3 ul liExecute GxP supplier qualification activities. /li liLead vendor qualification including document review and audit execution. /li liEnsure qualification of vendors providing GxP-relevant equipment and services. /li liAct as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls. /li liEstablish and Maintain Overview of already Qualified and to be Qualified Vendors. /li /ul h3Qualifications and experience: /h3 ul liRelevant working/residency permit or Swiss/EU-Citizenship required. /li liA Degree in life sciences and/or engineering. /li liAt least 5 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience. /li liDemonstrated experience in quality assurance and regulatory compliance with GxP, Swissmedic, US FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics. /li liDirect experience in quality oversight of GxP-compliant vendor qualification processes, including planning, documentation review, and audit execution. /li liDeep knowledge of GMP and global regulatory requirements, e.g. GMP, FDA, EU and other relevant GxP regulations. /li liEffective collaboration with internal and external stakeholders. /li liFluent in English (spoken and written). /li /ul /p #J-18808-Ljbffr