**R&D Site Quality Assurance Manager - German and Swiss Sites - Basel
Nr ref.: /JOBS.pl
As Site R&D QA Manager you are covering development activities in Switzerland Germany. The main objectives are to structure the quality approach at both sites, in line with R&D QA global strategy; to consolidate the quality environment of investigational products (drugs, cosmetics, medical devices); to prepare the sites to potential inspections. The direct reporting line will be to the Head of Preclinical and Pharmaceutical QA in France.
Ensure deployment, maintenance and follow-up of the Quality Management System dedicated to Development activities at the Swiss and German sites (Product development, Preclinical development): Provides support and expertise to the operational teams Participates in the elaboration of R&D QA strategies and general quality documents (policies, SOPs); authors or contributes to authoring QA documentation (procedures, instructions and forms) Hosts GMP and GLP regulatory inspections and third party audits of R&D activities Contributes to GxP quality training of the R&D employees Performs periodic management reviews of the activities and ensures follow up of planned remediation actions Contributes to regulatory surveillance Act as Responsible Person for all investigational products (cosmetics, investigational medical devices, investigational medicinal products) manufactured at the Swiss and German sites: Ensures review of investigational products batch documentation and proceeds to release for use in clinical trials; handles deviations and complaints Conduct internal and external audits of activities and vendors, and ensures appropriate follow-up. Conduct internal and external audits of activities and vendors, and ensures appropriate follow-up.
Master of Science or equivalent with a background in science or Quality Assurance. 10 years in Pharmaceutical industry, in Research & Development or Manufacturing Activities ideally, knowledge and experience of GLP and GCP requirements experience in Quality Assurance and GMP background mandatory good relationship skills, team-player Specific habitation required for the position: Languages: fluent in German and English Fulfils the requirements for applying to Swissmedic to act as a responsible person
This position involves national, regional, and international travel.
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
LinkedIn Search: Sam Caley Quality Assurance
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