QA/CAPA Expert

vor 1 Monat

Bern, Schweiz Randstad Vollzeit

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.

Johnson & Johnson Innovative Medicine is a global pharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

Main Responsibilities

  • Lead personnel and activities to establish and maintain quality systems NCs and CAPAs. This includes trending, analysis and reporting of quality metrics.
  • Serves as site trainer for the NC/CAPA process
  • Update and maintain Procedures, Work Instructions, and Forms for the quality system
  • Serves as a Point of Contact with the global NC/CAPA Business Processes Owners for assuring J&J requirements and standards are in place
  • Investigate, lead, and own site activities related to the NC/CAPA processes
  • Monitors site metrics and proactively takes action to ensure timeliness targets are met or exceeded
  • Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes Has thorough understanding of process criteria and regulations and business impact of decisions and actions
  • Lead monthly CAPA Review Board meetings and create status reports (monthly & quarterly reports, data analysis and trending for management)
  • Lead weekly Root Cause Analysis Board and provide support to the NC/CAPA users for a compliant execution of the process
  • Participate in ongoing identification of quality indicators/ metrics and development of improved data collection methods
  • Lead continuous quality system improvement efforts, including maintaining project schedules
  • Participate in and lead where necessary during the preparation and execution of any internal and/or external audits

    qualifications

    Who we are looking for

    • University degree in Natural Science, Medicine or Pharmacy
    • Profound knowledge of cGMP regulations and Quality Systems processes especially Nonconformances, Change Controls, Documentation Management and Training
    • Profound experience in facilitating and performing Root Cause Analysis
    • 5 - 8 years working experience in a GMP environment, preferably in Quality
    • English and German (fluently)
    • Strong ability in dealing with IT systems such as TrackWise
    • Strong written, oral, and presentation skills
    • Experience in biologicals manufacturing technologies is preferable
    • Experience or certification in Lean/Six methodologies preferred

      This job based in Bern, Switzerland will initially be limited to 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, inclusive, and collaborative environment, then send us your application today. Or give us a call if you have any questions

  • QA/CAPA Expert

    vor 1 Woche

    Bern, Bern, Schweiz Randstad Vollzeit

    JobdescriptionCaring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every...

  • QA/CAPA Expert

    vor 4 Wochen

    Bern, Schweiz Randstad Vollzeit

    JobdescriptionCaring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every...

  • NC/CAPA Expert

    vor 3 Wochen

    Bern, Bern, Schweiz Randstad Vollzeit

    Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout...

  • NC/CAPA Expert

    vor 3 Wochen

    Bern, Bern, Schweiz Randstad Vollzeit

    Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout...

  • NC/CAPA Expert

    vor 1 Monat

    Bern, Bern, Schweiz Randstad Vollzeit

    Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout...

  • NC/CAPA Expert

    vor 1 Monat

    Bern, Bern, Schweiz Randstad Vollzeit

    Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout...

  • QA Commercial

    vor 1 Woche

    Bern, Bern, Schweiz Techfirm Industrial Services Vollzeit

    For our _Techfirm Industrial Services_ team, we would like to integrate aQA commercial (M/W/D)ready to join us in Switzerland to take up new challenges togetherWHAT WILL BE YOUR TASKS Offer immediate support to operations and quality control teams to address any compliancerelated issues (onthefloor QA support). Make decisions related to quality independently...

  • QA Commercial

    vor 3 Wochen

    Bern, Schweiz Techfirm Industrial Services Vollzeit

    For our _**Techfirm Industrial Services**_ team, we would like to integrate a **QA commercial (M/W/D)** ready to join us in Switzerland to take up new challenges together! **WHAT WILL BE YOUR TASKS** - Offer immediate support to operations and quality control teams to address any compliance-related issues (on-the-floor QA support). - Make decisions...

  • Senior Agile QA Engineer

    vor 1 Woche

    Bern, Bern, Schweiz Galenica AG Vollzeit

    Senior Agile QA Engineer (f/m) 100% If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply. What you can do Execute both black-box and white-box testing for features developed by an Agile team. Own the design, implementation and execution of tests that will help ensure...

  • Senior Agile QA Engineer

    vor 4 Stunden

    Bern, Schweiz Galenica AG Vollzeit

    Senior Agile QA Engineer (f/m) 100%If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply.What you can doExecute both black-box and white-box testing for features developed by an Agile team. Own the design, implementation and execution of tests that will help ensure end-to-end quality...

  • Senior Agile QA Engineer

    vor 2 Wochen

    Bern, Schweiz Galenica AG Vollzeit

    Senior Agile QA Engineer (f/m) 100%If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply.What you can doExecute both black-box and white-box testing for features developed by an Agile team. Own the design, implementation and execution of tests that will help ensure end-to-end quality...

  • Senior Agile QA Engineer

    vor 22 Stunden

    Bern, Schweiz ictjobs (Stellenmarkt) Vollzeit

    Senior Agile QA Engineer (f/m) 100%If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply.What you can doExecute both black-box and white-box testing for features developed by an Agile team. Own the design, implementation and execution of tests that will help ensure end-to-end quality...

  • Senior Agile QA Engineer

    vor 2 Wochen

    Bern, Schweiz Galenica AG Vollzeit

    Senior Agile QA Engineer (f/m) 100% If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply. What you can do Execute both black-box and white-box testing for features developed by an Agile team. Own the design, implementation and execution of tests that will help ensure...

  • Data Integrity QA Site Lead

    vor 2 Monaten

    Bern, Schweiz CSL Vollzeit

    We are looking for a Data Integrity QA Site Lead Responsibilities: Advice and support site in Data Integrity related topics Support of the Global DI Program (e.g by supporting internal planning and alignment) Represent the site Quality Assurance department as expert in Data Integrity Lead local Data Integrity Steering Committee Qualifications: ...

  • Data Integrity QA Site Lead

    vor 3 Wochen

    Bern, Schweiz CSL Vollzeit

    We are looking for a Data Integrity QA Site Lead Responsibilities: Advice and support site in Data Integrity related topics Support of the Global DI Program (e.g by supporting internal planning and alignment) Represent the site Quality Assurance department as expert in Data Integrity Lead local Data Integrity Steering Committee Qualifications: ...

  • Scientific Expert, QA Plasma

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    Für die Gruppe Plasma & Intermediates Release Management des **Bereichs Quality Assurance Batch Release **innerhalb des Departements **Site Quality** suchen wir eine/n **Scientific Expert, 100%**: **Kompetenzen und Verantwortlichkeit** Innerhalb der Gruppe Plasma & Intermediates Release Management befassen wir uns mit der Freigabe unseres wichtigsten...

  • Data Integrity QA Site Lead

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    We are looking for a Data Integrity QA Site Lead to join our team at CSL Behring Bern site. Partnering closely with the Global Data Integrity Business Process Owner and other Quality functions to continuously improve and standardize the DI processes and standards across the network of responsibility.ResponsibilitiesAdvice and support site in Data Integrity...

  • Data Integrity QA Site Lead

    vor 3 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    We are looking for a Data Integrity QA Site Lead to join our team at CSL Behring Bern site. Partnering closely with the Global Data Integrity Business Process Owner and other Quality functions to continuously improve and standardize the DI processes and standards across the network of responsibility.ResponsibilitiesAdvice and support site in Data Integrity...

  • Senior Agile QA Engineer

    vor 1 Woche

    Bern, Bern, Schweiz Galenica AG Vollzeit

    "Go further in the fascinating world of health and well-being." Senior Agile QA Engineer (f/m) 100% 3010 Bern Galenica AG Region Mittelland (BE, FR, SO, NE, JU, VD) IT If you are a passionate and experienced Agile QA who is looking for a challenging and rewarding role, we encourage you to apply. What you can doExecute both black-box and white-box testing...

  • Data Integrity QA Site Lead

    vor 4 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    We are looking for a Data Integrity QA Site Lead to join our team at CSL Behring Bern site. Partnering closely with the Global Data Integrity Business Process Owner and other Quality functions to continuously improve and standardize the DI processes and standards across the network of responsibility.Responsibilities:Advice and support site in Data Integrity...