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senior specialist product quality // johnson & johnson.

détails du poste

sommaire.

  • catégorie
    life sciences
  • contact
    Stephan Zoebeli
  • référence
    127140-526

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détails du poste

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:

  • Provide Microbiological Quality Assurance expertise to site units to ensure appropriate state of microbial control.
  • Ensure that manufacturing processes, meet Microbiological Quality Assurance principles and requirements.
  • Ensure that new manufacturing processes, or process changes meet Sterility Assurance principles and requirements.
  • SME for non-conformities and CC related to environmental monitoring and microbiological excursions
  • Review and approval of non-conformities, CAPAs, and Change Controls related to environmental monitoring and microbiological excursions.
  • Support the maintenance, development, and improvement of Microbiological Quality processes.
  • Support site Quality Aseptic Processing Oversight Program
  • Review of executed batch records for aseptic process simulation
  • Review and approval of documents, e.g. SOPs, work instructions and risk assessments, master batch records
  • Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and marketed product
  • Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time
  • Contact person for production, development, and quality control for product quality related topics
  • Support the achievement of KPIs
  • Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers

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:

  • Provide Microbiological Quality Assurance expertise to site units to ensure appropriate state of microbial control.
  • Ensure that manufacturing processes, meet Microbiological Quality Assurance principles and requirements.
  • Ensure that new manufacturing processes, or process changes meet Sterility Assurance principles and requirements.
  • SME for non-conformities and CC related to environmental monitoring and microbiological excursions
  • Review and approval of non-conformities, CAPAs, and Change Controls related to environmental monitoring and microbiological excursions.
  • Support the maintenance, development, and improvement of Microbiological Quality processes.
  • Support site Quality Aseptic Processing Oversight Program
  • Review of executed batch records for aseptic process simulation
  • Review and approval of documents, e.g. SOPs, work instructions and risk assessments, master batch records
  • Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and marketed product
  • Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time
  • Contact person for production, development, and quality control for product quality related topics
  • Support the achievement of KPIs
  • Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers

informations de contact.

nous sommes à ta disposition pour toute question.

SZ

Stephan Zoebeli

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