job details veröffentlicht 26. Juli 2017 Ort Switzerland Sektor Life Sciences Jobtyp Permanent Referenznummer 9629 Kontakt Barbara Sorce, Basel Professionals Health Care & Life Sciences Telefon 058 201 55 50 jetzt bewerben E-Mail senden Stellenbeschreibung Our client, a world-wide pharmaceutical industry specialized in the synthesis of active pharmaceutical ingredients is looking for a Quality Assurance Manager Location: Neuchatel area, Switzerland Contract: permanent Start date: asap Tasks Support the implementation and execution of the Quality Management Review process and to ensure compliance with ISO 9001 as well as local regulatory requirements. Conduct of inspections / audits with Authorities (FDA, EMEA) and clients Management of internal and external audits (suppliers) Assessment and follow-up of complaints, deviations, Change Control, OOS, CAPA Drafting of protocols and validation and qualification reports, Site Master File, GMP Training, Annual Management Review, Product Quality Review (PQR) Writing, modifying, reviewing and distributing the procedures (SOP) of the whole company Requirements: Master’s degree in Life Sciences, preferible Chemistry. At least 3-5 years of in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices, Biotech. Excellent working knowledge/understanding of ISO and International Conference on Harmonization (ICH) Q8, Q9, Q10 requirements. In-depth knowledge of current standards in the pharmaceutical (CGMP, ICH, USA CFR, GDP). Knowledge in Regulatory affairs is an additional asset. Fluent in both written / spoken French and English (proficiency in Italian would be an asset) Strong customer focus, communication, presentation and interpersonal skills, to ensure cross-functional collaboration. Self-motivated, result-oriented, proactive, purposeful, efficient and enthusiastic. Fluent in both written / spoken English (proficiency in French would be an asset). Flexible and can travel internationally up to 50% would be ideal. Experience in conducting audits and in working on audit report submission and follow up would be preferred. We are looking forward to receiving within your application: your CV in English latest Work Certificates your Motivation Letter ID/passport copy Apply now to be considered – Good to know you! For more information and your application, please contact: Barbara Sorce, Team Leader Life Science Professionals, M +41 79 376 00, barbara.sorce@ch.randstad.com teilen: Facebook LinkedIn Twitter Xing