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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
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. 400 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.
Aim of the position
Ensuring that products, materials for production, systems and facilities are in state of sustainable compliance with GMP requirements
Provide quality guidance to all departments on site for the different cGMP related subjects
Support the execution of health and non-health authorities inspections
Main Responsibilities
Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and commercial products
Contact person for production, development, and quality control for all product quality related topics
Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time
Review of Process Description and (electronic) master batch records (MBR)
Review of executed (electronic) batch records
Preparation for batch disposition
Release planning activities for manufactured products
Ensure the consistent quality of produced materials
QA oversight for aseptic processing
Review and approval of non-conformities, and Change Controls
Ensure the relevancy and effectiveness of corrective and preventive actions
Review and approval of Standard Operating Procedures, Work Instructions and Risk Assessments
Support Annual Product Review
LIMS profiles approval for produced materials and stability studies
SAP Set up for produced material
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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
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. 400 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.
Aim of the position
Ensuring that products, materials for production, systems and facilities are in state of sustainable compliance with GMP requirements
Provide quality guidance to all departments on site for the different cGMP related subjects
Support the execution of health and non-health authorities inspections
Main Responsibilities
Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and commercial products
Contact person for production, development, and quality control for all product quality related topics
Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time
Review of Process Description and (electronic) master batch records (MBR)
Review of executed (electronic) batch records
Preparation for batch disposition
Release planning activities for manufactured products
Ensure the consistent quality of produced materials
QA oversight for aseptic processing
Review and approval of non-conformities, and Change Controls
Ensure the relevancy and effectiveness of corrective and preventive actions
Review and approval of Standard Operating Procedures, Work Instructions and Risk Assessments
Support Annual Product Review
LIMS profiles approval for produced materials and stability studies
SAP Set up for produced material
