Jobsuche und Projektbörse
für Fach- und Führungs­kräfte

Goldach | Festanstellung durch unseren Kunden | Startdatum: sofort | 461250/1
Verantwortung für DHF RA (Ordnerführung, Ablage) Technische Dokumentationen (Hauptdokument, Nachweis Grundlegende Anforderungen, Risiko Management-Akte, Gebrauchstauglichkeit) aller mechanischen und elektronischen Produkte erstellen und aktuell halten Auftragserteilung und Korrespondenz mit Prüflabor bei externen Prüfungen (el. Sicherheit, EMV) Erstellung der Pflichtenhefte bei Neuentwicklungen sowie Erstellung der Verifikations- und Validierungspläne Durchführung der Verifikation Bereitstellung von klinischen Bewertungen mit Fachärzten Erstellung von Softwaredokumentationen nach EN 62304 Nachweise der Biokompatibilität beschaffen Reinigungs-/Sterilisationsvalidierungen mit Prüflabor durchführen Betreuung der regelmässigen CSA-Audits in der Produktion Durchführung von internationalen Produktzulassungen (CE, CSA, FDA, Heath Canada, usw.) Länderspezifische Registrierungen mit Verkauf durchführen
Zofingen | Festanstellung durch unseren Kunden | Startdatum: sofort | 441115/1
Selbstständige Administration eines Bereiches (Vertragserstellung, Zeugnisse, Einholen von Bewilligungen, usw.) Ansprechpartner für Mitarbeiter und Linienvorgesetzten in allen relevanten HR-Fragen Selbständige Rekrutierung Zuständig für die Zeiterfassung und das Absenzenmanagement Sicherstellung der Umsetzung von HR Prozessen und Sicherstellung eines reibungslosen HR Ablaufes Mitarbeit bei Weiterentwicklung von HR-Prozessen und in HR-Projekten Stellvertretung innerhalb des Teams
Aargau | Festanstellung durch unseren Kunden | Startdatum: sofort | 449600/1
Praktische Begleitung von analytischen Projekten im Bereich Drug Substance von der frühen Entwicklungsphase bis hin zur Prozessreife Entwickeln und Optimieren von nasschemischen und spektroskopischen Analysenmethoden (z.B. Karl-Fischer, Titration, ICP/MS, IR, UV/Vis, Korngrössen-Bestimmung) Implementieren, Validieren und Transferieren von Methoden Analysieren pharmazeutischer Wirksubstanzen und Zwischenprodukte, teilweise unter cGMP Mithilfe bei Unterhalt und Betreuung unseres modernen Geräteparks
Solothurn | Festanstellung durch unseren Kunden | Startdatum: sofort | 407615/1
Sie arbeiten sowohl mit Führungskräften als auch HR Business Partnern zusammen, bringen sich im Rahmen von Projekten aktiv ein und gestalten zukunftsweisende Konzepte im HR-Umfeld mit Sie beraten und betreuen Führungskräfte bei der Umsetzung von HR Prozessen (Performance-, Compensation-, Talent- und Succession Management) Sie steuern u.a. den Onboarding-Prozess für Führungskräfte und Mitarbeitende Ihres Betreuungsbereiches und sind Ansprechpartner für arbeitsrechtliche Fragestellungen Sie sind für die Erstellung und Pflege strategischer HR-Kennzahlen verantwortlich
Zug | Permanent employment with our customer | Startdatum: sofort | 449295/1
You will be responsible, for a portfolio of products, to deliver to the Swiss market high quality level products You will be the Quality Business Partner for the BU Genzyme, Consumer Health Care and Pasteur and be integrated in any launch activities and Supply and Operational activities to ensure a strong quality leadership to the Business units You will autonomously manage batch releases, deviations, returns and destructions as well as provide support to the responsible person in leading product quality alerts, notifications and recalls You will supervise packaging and re-packaging activities in close collaboration with Supply Chain and Regulatory affairs You will supervise from a quality standpoint the external distribution center for Switzerland You will manage all third parties for Sanofi Switzerland and perform audits to third parties You will provide support to the Responsible Person during health authorities inspections You will represent the company in national association workgroups linked to RP responsibilities
Zürich | Permanent employment with our customer | Startdatum: sofort | 444524/1
Review of FDF produced by contract partners Batch record review and continuous product quality follow-up and PQR management Deviation/Complaint Management/Audits/Assessing deviation reports received from CMO Support handling, responding, tracking of complaints being received by customers Participate in internal and CMO audits incl. CAPA follow-up and (re-)audit coordination Change management / Documentation approval and evaluate change requests received from CMO/CRO/API manufacturer from a Regulatory and GMP point of view Initiate internal change requests Product dossier updates, review of updates received from CRO/CMO or regulatory service providers, identification of deficiencies Participate in development of variation submission strategy for finished products dossiers Track variations submitted in different countries and by different customers
Vaud | Permanent employment with our customer | Startdatum: sofort | 447830/1
Perform safety profiling and participate in compounds selection, including on/off target toxicity Manage preclinical safety studies in Contract Research Organizations Contribute to the preparation of preclinical safety regulatory documents (IDB, summaries for IND and IMPD) Perform mechanistic studies on toxicology findings Identify early toxicology biomarkers for preclinical and clinical studies Work in matrix organization in close collaboration with other Translational Medicine functions Participate in internal and external scientific communications
Vaud | Permanent employment with our customer | Startdatum: sofort | 447831/1
Clinical pharmacology assessments in oncology trials Pharmacometrics PK/PD Pharmacokinetics/Pharmacodynamics QTQ Clinical pharmacology studies from conception to final report First-in-human studies (SAD, MAD), bioequivalence, food effect, drug-drug interactions, TQT, special populations PK and ADME studies Collaboration with different internal stakeholders to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes Clinical dose selection and dose adjustment Reviewing documentation for regulatory submissions, INDs and NDAs
Baar | Permanent employment with our customer | Startdatum: sofort | 418000/1
Deviation, Complaints & CAPA: ensure the timely tracking and appropriate investigation, impact assessment, close out in collaboration with partners and contractors Ensure appropriate corrective and preventive actions are defined, implemented and that their efficacy is evaluated KPI: collect and perform trend analyses based on indicators as well as feedback from other department and take actions as adequate Perform the periodical performance evaluation of the contract manufacturing organisations in collaboration with other concerned departments Regulatory Inspections: coordinate the preparation of CMOs and internal departments as well as attend on site as needed or on call Perform risk assessments as preventive measures or in response to product/quality system failures, investigations and regulatory observations Prepare and present information, contributing to reject/recall decisions Perform quality review and approval for change requests with impact to contract manufacturing or related supply chain operations with particular focus for finished goods activities and artworks Responsible for quality aspects related to the transfer or set-up of processes related to clinical and commercial small molecules API / drug products / finished products to all contract manufacturing organisations but not limited to risk assessments, validations protocols and reports review and approval, defining and following up on all quality aspects Participate in cross-functional reviews of regulatory files prior to submission, for area of competence Quality Management Review meetings: support their organisation and lead the meeting with contract manufacturing organizations

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