Audit & Capa Lead (P2307)

vor 5 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._

For our Quality organization based at our Headquarters in Lausanne, we are looking for a

**Audit & CAPA Lead**

**Your responsibilities will be but not limited to**:

- Audit & CAPA process owner
- On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Quality & Business representatives with regards to system related questions.
- Ensure the risk-based audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
- Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
- In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents, etcto adequately assess compliance with DPI Procedural Documents and applicable regulations.
- Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
- Contribute to preparation and conduct activities of Regulatory Authority Inspections.
- Work with GxP Quality Lead in view of adequate and timely CAPA development.
- Oversee / Manage Quality Coordinator to populate the Audit / CAPA system as per Audit / CAPA process requirements.
- Develop meaningful Audit / CAPA metrics allowing proper oversight / follow-up by business representatives (owners & department heads).
- Generate Audit / CAPA metrics to indicate areas for improvement and to drive continuous improvement initiatives.

**Requirements**:

- University degree: Pharmacist Diploma, PhD, master’s in science
- 5 to 8 years’ experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
- Minimum 3 years’ experience with GxP Audits
- Minimum 3 years ‘experience in managing tracking systems such as CAPAs database resulting from GxP audits (ex for GCP: CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems
- Solid knowledge of GxP
- Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
- Knowledge of computerized systems validation
- Rigor, flexibility, adaptability, and organization
- Pragmatism focused on efficiency and continuous improvement
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities

**Benefits**

**Debiopharm can offer you**
- Possibility to work from home with weekly visit in the office (Lausanne)
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._

  • Audit & Capa Lead (P2307)

    vor 5 Stunden

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Audit & Capa Lead - Temporary (8 Months)

    Vor 7 Tagen

    Lausanne, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for an Audit & CAPA Lead to join a brilliant biotech establishment on a contract basis located in Lausanne. Our client is focused on improving people's quality of life through consistent novelty. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this...

  • P2335 - Clinical Development Quality Lead

    vor 1 Woche

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • P2335 - Clinical Development Quality Lead

    vor 1 Woche

    Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...

  • P2244 - Clinical Development Quality Lead

    Vor 4 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...

  • Clinical Development Quality Team Lead

    vor 1 Tag

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Consultant Gestion Qualité

    vor 3 Wochen

    Lausanne, Schweiz LB Recrutement Vollzeit

    Mission temporaire de 3-5 mois **Responsabilités: - Enregistrement de l'écart, traitement et suivi, archivage - Gestion des demandes de modification (Change Control) - Gestion de la CAPA. Mise à jour des mesures définies suite aux audits internes et externes. - Gestion de la documentation contrôlée ; rédaction et révision des SOP. - Gestion des...

  • Quality Assurance Manager

    vor 8 Monaten

    Lausanne, Schweiz Panda International Vollzeit

    **Quality Assurance Manager**: **Location** - Lausanne, Switzerland **Business Sector** - Biotechnology **Job ref** - 22069 **Published** - about 1 month ago Our client, a renowned leader in the field of immunotherapy, dedicated to pushing the boundaries of science to transform the lives of patients is currently seeking a highly experienced and strategic...

  • Quality Engineer

    Vor 4 Tagen

    Lausanne, Schweiz i-Pharm GxP Vollzeit

    Quality EngineerWe’re seeking an experienced Quality Engineer to lead initiatives in compliance, CAPA resolution, and quality systems remediation for medical devices and combination products. This is a fantastic opportunity for professionals passionate about driving quality improvements in a dynamic and regulated manufacturing environment.Key...

  • Audit Director Lausanne, Switzerland Finance

    vor 7 Monaten

    Lausanne, Schweiz Philip Morris International Vollzeit

    Audit Director Purpose of the Job With PMI’s journey towards a smoke-free future and a consumer-centric organization, the company faces new opportunities and risks. To safeguard the company’s business objectives, ensure its delivery against strategic opportunities, and protect the company against emerging uncertainties, a highly professional and...

  • Accounting Lead

    vor 7 Monaten

    Lausanne, Schweiz Quantis Vollzeit

    **WHY YOU’LL LOVE QUANTIS** Quantis is a leading sustainability consultancy pioneering approaches to solve critical environmental challenges. For nearly two decades, our dynamic and visionary team has partnered with organizations across the globe to transform their industries and pave the way for a planetary economy that aligns business with nature. We...

  • Quality Engineer

    vor 3 Monaten

    Lausanne, Schweiz The Biopôle Vollzeit

    Responsibilities:Serve as the quality reference for development and implementation of quality documentation related to the design technology and to the manufacturing process (i.e. Specifications, Validation Master Plan, Quality Plan, Process Validation Protocols and Reports).Interface with all partners involved in the development, manufacturing, and quality...

  • Technical Solutions Lead

    vor 19 Stunden

    Lausanne, Waadt, Schweiz Experis Switzerland Vollzeit

    About the Role:We are seeking a highly skilled and experienced Technical Solutions Lead to join our team and lead the deployment of IT solutions.This individual will design and develop architectures for IT tools, create comprehensive standards that encompass network and computing elements, ensuring adherence to security constraints and industry best...

  • Lead Auditor

    vor 4 Wochen

    Lausanne, Waadt, Schweiz RSM International Vollzeit

    RSM International is a leading global network of audit, tax, and advisory firms. We are committed to delivering exceptional services to our clients, with a focus on providing personalized support and guidance. As a Senior Auditor at RSM Switzerland, you will play a critical role in helping us achieve this goal.About the RoleAs a Senior Auditor, you will be...

  • Responsable Qualité

    vor 1 Woche

    Lausanne, Schweiz Axepta SA Vollzeit

    **L'agence Axepta recherche pour l'un de ses meilleurs partenaires, entreprise experte dans son domaine qui se localise près de Lausanne**: **RESPONSABLE QUALITE H/F** **POSTE**: - Gérer les activités liées à l'AQ pour l'usine suisse avec le soutien de la structure du groupe. - Mettre en oeuvre la politique et les normes d'AQ en suivant les directives...

  • QA Gcp Auditor

    vor 8 Monaten

    Lausanne, Schweiz Panda International Vollzeit

    **QA GCP Auditor**: **Location** - Lausanne, Switzerland **Business Sector** - Biotechnology **Job ref** - 22251 **Published** - about 7 hours ago Our client, a dynamic clinical stage biopharmaceutical company, is actively seeking a highly skilled and motivated QA GCP Auditor to join their Quality Assurance team. This role is pivotal in ensuring the...

  • Manager QA Ops

    vor 5 Stunden

    Lausanne, Schweiz Axepta SA Vollzeit

    Nous recherchons pour notre client spécialisé dans les dispositifs médicaux un manager QA ops pour compléter son équipe proche de Lausanne. Responsabilités: - Gestion de l'équipe chargée des opérations d'assurance qualité - Accompagnement des membres de l'équipe afin d'optimiser leurs performances et garantir leur formation - Soutien à la mise...

  • Spécialiste de Qualité au Laboratoire

    vor 19 Stunden

    Lausanne, Waadt, Schweiz AXEPTA SA Vollzeit

    Découvrez le rôle clé du Spécialiste de Qualité au LaboratoireLe Spécialiste de Qualité au Laboratoire est responsable de la qualité des produits microbiologiques, des contrôles en cours de fabrication et des matières premières.Tests et Analyses Microbiologiques : Assurer les tests microbiologiques pour garantir la qualité des produits.Suivi...

  • QC Microbiology expert

    vor 2 Wochen

    Lausanne, Schweiz Expleo Technology Switzerland Vollzeit

    The QC Expert Microbiology is responsible for the QC Microbiology operational activities, new equipment implementation and tech transfer/projects related to Drug Substance (DS), In-Process-Control (IPC) testing & release, and Environmental and Utilities Monitoring and control.The consultant owns the deviations, CAPA and change controls for the QC activities...

  • Translational Medicine G(C)lp Quality Lead

    vor 5 Stunden

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...