CK QLS are recruiting for a Compliance Specialist role to join a global biopharmaceutical company at their biological development and manufacturing site based at their site in Luzern. This role is offered on a contract basis till end 2020.
Compliance Specialist Role:
- Supporting the reorganization from a compliance perspective of the revision of local SOP; supporting the preparation of the Health Authority Inspection; organizing training of Regulatory Affairs team and ensuring readiness for the planned reorganization.
- Supporting the team in maintenance activities of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- Ensuring timely preparation and maintenance of local Product Circular, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards and Artwork Management procedures.
- Ensuring high quality translations and check of Product Circular and Patient Package Leaflets including linguistic and format check of these documents.
- Ensuring availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
- Ensuring efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland.
- Master's or Bachelor's degree in Pharmaceutical Sciences or another relevant Life Science discipline.
- Fluency in German, English and French is required.
- Previous experience in a registration department, regulatory agency or another related environment, include direct contact with regulatory agencies.
- Experience in compliance activities like SOP writing, training activities.
- Familiarity with Swiss and (if applicable) EU legislation procedures and guidelines governing pharmaceutical products; knowledge of the regulatory framework for vaccines is advantageous.
- Demonstrated diplomacy and assertive skills in dealing with internal and external parties.
- Proficient use of MS Office suite and relevant database application.
Apply: For more information or to apply for this Compliance Specialist position, please contact Dennis on 0041 (0) 78 250 84 43 or email email@example.com, quoting job ref 48530.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.