Cqv / Csv Consultant

vor 3 Wochen

Bern, Schweiz Consultys Vollzeit

As part of our development, we are recruiting a CQV/CSV Consultant to join our teams.
- Assess laboratory instruments and software for their compliance with Data Integrity guidelines.
- Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with client guidelines.
- Manage local and global qualification and validation projects.
- Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities.
- Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.
- Collaborate with relevant stakeholders to ensure laboratory are complient with Data Integrity guidelines by implementing a Data Audit Trail Review process.

Requirements:

- University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
- 3+ years’ experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
- First project management experience in an operational environment.
- Knowledge of regulations on computerized systems and laboratory automation, and a willingness to extend skills and know-how in the field.
- Strong written and verbal communication skills in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally.

proactive and self-responsible approach
- Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.
- Ability to work independently and as a team member in a high-performance environment.

Qui sommes nous ?

For more than 19 years, through our consulting and engineering activities, we have supported our clients throughout the entire lifecycle of biotechnology, pharmaceutical and device products.

Part of an organization of more than 750 Life-science experts, Consultys Switzerland supports and develops talented individuals recognized for their technical and scientific expertise. Our activities allow us to be present in both French-speaking and German speaking Switzerland, with agencies in Lausanne and Basel.

At Consultys, we're proving that it's possible to combine people and performance.

Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group's success.

  • Cqv Manager

    vor 4 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    CQV Manager **Job Description**: **Job Summary**: The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building Infrastructure,...

  • Cqv Manager

    vor 5 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    CQV Manager **Job Description**: **CQV Manager** **Job Summary** The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building...

  • Cqv Manager

    vor 4 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    **CQV Manager** **Job Summary** The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building Infrastructure, Utility, HVAC/Areas,...

  • Cqv Manager

    vor 3 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    CQV Manager - Switzerland **Job Description**: **Job Summary**: The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building...

  • Cqv Manager

    vor 4 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    Job Summary The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building Infrastructure, Utility, HVAC/Areas, Automation and Process...

  • Csv Consultant

    vor 4 Monaten

    Bern, Schweiz Experis Vollzeit

    CSV Consultant **Experis is the global leader in professional resourcing and project-based workforce solutions.** **For our client, a leading Pharmaceutical company in Bern, we are looking for a CSV Consultant.** **Location: Bern** **Duration of contract: 9 months** **Responsibilities** You will be in charge of Computer System Validation (CSV)...

  • Consultant CSV

    vor 1 Monat

    Basel, Bern, St. Gallen, Zürich, Schweiz adesso Schweiz AG Vollzeit

    Consultant CSV / IT Quality ConsultantBasel Bern St. Gallen ZürichARBEITEN BEI EINEM DER BESTEN ARBEITGEBER DER SCHWEIZWir gehören zu den Top-Adressen in der IT-Welt und fokussieren uns auf die Optimierung der Kerngeschäfts­prozesse unserer Kunden. Durch den smarten Einsatz maßgeschneiderter IT-Lösungen unterstützen wir unsere Kunden dabei, das Beste...

  • CSV Consultant

    Vor 7 Tagen

    Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit

    About the RoleAvacone Iberia S.L. is seeking a highly skilled CSV Consultant to join our team. As a CSV Consultant, you will be responsible for managing and executing CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.Key ResponsibilitiesEvaluate and create gap analyses, CSV documents, and data governance...

  • CSV Consultant

    vor 2 Wochen

    Bern, Schweiz Avacone Iberia S.L. Vollzeit

    We are looking for motivated colleagues to join our team.What you will doManagement and operational execution of CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.Evaluation and creation of gap analyses, CSV documents and data governanceEnsuring compliance with the relevant regulations with a focus on data...

  • CSV Consultant

    Vor 2 Tagen

    Bern, Schweiz Avacone Iberia S.L. Vollzeit

    We are looking for motivated colleagues to join our team.What you will doManagement and operational execution of CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.Evaluation and creation of gap analyses, CSV documents and data governanceEnsuring compliance with the relevant regulations with a focus on data...

  • CSV Specialist

    vor 10 Stunden

    Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit

    CSV ConsultantWe are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.Key ResponsibilitiesAs a CSV Consultant, you will be responsible for managing and executing CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification, or QA Services.Key tasks include:Evaluation and creation of gap analyses, CSV...

  • CSV Specialist

    vor 10 Stunden

    Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit

    Job Title: CSV ConsultantWe are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.Key ResponsibilitiesAs a CSV Consultant, you will be responsible for:Managing and executing CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification, or QA Services.Evaluating and creating gap analyses, CSV documents, and...

  • CQV Engineer

    vor 4 Monaten

    Bern, Schweiz Agap2 Vollzeit

    Share: Information Location: Bern Position: CQV Engineer (Pharma/Biotech) Sector: Life Science Type of contract: Permanent Starting date: Within 3 months Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Life Science, Energy, Infrastructure, Transportation, Chemicals...

  • Senior Validation Specialist

    Vor 6 Tagen

    Bern, Bern, Schweiz Agap2 Vollzeit

    About the RoleWe are seeking a highly skilled CQV Engineer to join our team at Agap2. As a consultant, you will be responsible for supporting clients in various projects within the Life Science sector.Main Responsibilities:Preparation and execution of Commissioning & Qualification activitiesEnsuring milestone dates are achievedProviding support in Design...