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quality assurance specialist (sap key user) // johnson & johnson.

Job Details

zusammenfassung.

  • Branche
    Life sciences
  • Kontakt
    Stephan Zoebeli
  • Referenznummer
    127140-522

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Job Details

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 the Johnson & Johnson Family of Companies 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 140,000 people.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical 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:

  • SAP Key User (local & global projects)
  • Contact person for production, development, and quality control for all quality related topics
  • Ensure the quality of materials for production and supplier
  • Ensure that deliverables assigned to LMM as part of projects are successfully achieved on time
  • Review and release of batches of purchased materials and conduct their qualification
  • QC Oversight for review of process documents
  • Support the GMP-compliant production of active ingredients and drugs for clinical trials and market launch
  • Support Product MBR review
  • Support review of executed batch records
  • Support QA oversight for aseptic processing
  • Review and approval of non-conformities, CAPAs, and Effectiveness Checks
  • Assessment and Implementation of Change Controls
  • Ensure the relevancy and effectiveness of corrective and preventive actions
  • Review and approval of SOPs, work instructions and risk assessments
  • LIMS profiles' approval for Materials for Productions
  • SAP Set up for Materials for Production
  • Support Quality Operations and Product Quality to ensure GMP readiness for NPI projects
  • Support for internal and external audits as subject matter expert
  • Support for risk management at the site
  • Support development and deployment of KPIs and Metrics to support continuous improvement.
  • Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers
  • Support the execution of audits from the corporate compliance including responding to the audit report
  • Support the response to reports from external inspection and audits

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 the Johnson & Johnson Family of Companies 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 140,000 people.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical 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:

  • SAP Key User (local & global projects)
  • Contact person for production, development, and quality control for all quality related topics
  • Ensure the quality of materials for production and supplier
  • Ensure that deliverables assigned to LMM as part of projects are successfully achieved on time
  • Review and release of batches of purchased materials and conduct their qualification
  • QC Oversight for review of process documents
  • Support the GMP-compliant production of active ingredients and drugs for clinical trials and market launch
  • Support Product MBR review
  • Support review of executed batch records
  • Support QA oversight for aseptic processing
  • Review and approval of non-conformities, CAPAs, and Effectiveness Checks
  • Assessment and Implementation of Change Controls
  • Ensure the relevancy and effectiveness of corrective and preventive actions
  • Review and approval of SOPs, work instructions and risk assessments
  • LIMS profiles' approval for Materials for Productions
  • SAP Set up for Materials for Production
  • Support Quality Operations and Product Quality to ensure GMP readiness for NPI projects
  • Support for internal and external audits as subject matter expert
  • Support for risk management at the site
  • Support development and deployment of KPIs and Metrics to support continuous improvement.
  • Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers
  • Support the execution of audits from the corporate compliance including responding to the audit report
  • Support the response to reports from external inspection and audits

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SZ

Stephan Zoebeli

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