Senior QA Compliance Expert - Freelancer

Job OverviewFor our Swiss and EU based pharmaceutical clients we are seeking an experienced Senior QA Compliance Specialist fulfilling also the requirements to act as “Fachtechnisch verantwortliche Person (FvP)” according to Swiss Arzneimittel-Bewilligungsverordnung (AMBV), as well as “verantwortliche Person Betäubungsmittel) according to Swiss Betäubungsmittelkontrollverordnung (BetmKV).Key ResponsibilitiesConsulting of clients in all kind of Quality Assurance/Management aspectsExecution on client projects in the area of Quality Assurance/ManagementExecution of all tasks arising from the AMBV, in particular:Market release/non-release decision of pharmaceutical productsEnsuring the required quality of the pharmaceutical products marketed in Switzerland along the whole value chain, i.e. procurement, production, quality control, warehousing and distributionInterface to the local competent authoritiesEnsure compliance with actual product registration filesPreparation and execution of audits and inspectionsAssessment of pharmaceutical law requirements when importing medicinal productsReview and approval of GxP-relevant SOPsApproval of critical deviations, OOS and complaints related to the marketed productsExecution of recalls related to the marketed productsExecution of self-inspections in relation to the above-mentioned responsibilitiesExecution and oversight of all tasks arising from BetmKVSupport business development activities in the QA compliance areaContribute to develop the QA compliance services and capabilities according to market needs and trendsQualifications, Skills and ExperienceUniversity degree in pharmacy or closely related science fieldFulfillment of the requirements as FvP as per Swiss AMBVFulfillment of the requirement as vP Betäubungsmittel as per Swiss BetmKVAt least 5 years of active work in quality management, preferably in the pharmaceutical industryIdeally work experience as FvP according to Swiss Arzneimittel Bewilligungsverordnung (AMBV)In-depth knowledge of Swiss national and international pharmaceutical law, as applicableExcellent communication across hierarchies, disciplines and culturesIndependence, willingness to take responsibility and decisivenessVery good written and spoken German and English skills, French beneficial