CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Full-timeOn-siteExperienced
Neuenburg
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Preparing product quality reviews and regulatory documentation for therapies in GI, oncology, and rare diseases. 3-5 years biotech/pharma manufacturing experience with eCTD license review essential. 28 days PTO, sport/fitness contribution, preventive healthcare support.
Requirements
- University degree in technical/scientific discipline such as biochemistry, chemistry, engineering, or equivalent
- At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry
- Experience in writing and/or reviewing eCTD licenses (quality - module 3)
- Experience with the regulatory affairs framework (CMC)
- Good knowledge of FDA, EMA, ICH regulations and quality system standards
- Experience as a change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory/quality standards
- Fluency in English and French
- Knowledge/Experience with quality tools such as Trackwise 8, Veeva, eCTD viewer
- Good knowledge of FDA, EMA, ICH regulations and quality system standards
- Experience as a Change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory/quality standards
- Work in a controlled environment requiring special gowning and protective clothing
- Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails
- Work around chemicals such as alcohol, acids, buffers that may require respiratory protection
Tasks
- Prepare Product Quality Reviews (PQR) annually for products manufactured at the Neuchâtel facility
- Review global release specifications and implement updated versions for Neuchâtel products
- Participate in GMP tours to ensure inspection readiness
- Manage and prepare documentation for regulatory submissions and major change projects
- Prepare and review documentation for change controls, audit observations, and regulatory agency inquiries
- Support and write responses to regulatory agency questions, collaborating with Subject Matter Experts as needed
- Assist in the preparation of inspections and required documents
- Participate in audits and inspections as required
- Help define strategies for responses to health authority questions as part of the quality matrix team
- Update inspection records in TrackWise when necessary
- Propose initiatives to improve and streamline quality tasks
- Assist in the preparation and review of quality documentation as needed
- Participate in Quality Council meetings as necessary
- Support coordination of site Key Performance Indicators (KPIs)
- Participate in project teams based on expertise and project focus
- Engage in product launch activities
- Identify opportunities to enhance quality processes
- Collaborate with global Quality Product Leads and Regulatory Affairs partners
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- French – Business Fluent
Tools & Technologies
- Trackwise 8
- Veeva
- eCTD viewer
Benefits
More Vacation Days
- 28 days of paid time off
Healthcare & Fitness
- Sport/Fitness abonnement contribution
- Medical annual check-ups starting at age 50
- Financial support for preventive healthcare
Free or Subsidized Food
- On-site cafeteria
Generous Parental Leave
- Paid leave for maternity
- Paid leave for paternity
- Paid leave for adoption
Childcare
- Dedicated spaces for nursing mothers
Learning & Development
- Access to a Learning Catalog
- Language courses
Career Advancement
- Opportunities for internal mobility
Workation & Sabbatical
- Opportunities for international mobility
Public Transport Subsidies
- Contributions for public transport
Company Bike
- Incentives for e-biking
Parking & Commuter Benefits
- On-site charging stations for electric vehicles
Team Events
- Regular on-site gardening activities
Mental Health Support
- Regular on-site massages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Preparing product quality reviews and regulatory documentation for therapies in GI, oncology, and rare diseases. 3-5 years biotech/pharma manufacturing experience with eCTD license review essential. 28 days PTO, sport/fitness contribution, preventive healthcare support.
Requirements
- University degree in technical/scientific discipline such as biochemistry, chemistry, engineering, or equivalent
- At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry
- Experience in writing and/or reviewing eCTD licenses (quality - module 3)
- Experience with the regulatory affairs framework (CMC)
- Good knowledge of FDA, EMA, ICH regulations and quality system standards
- Experience as a change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory/quality standards
- Fluency in English and French
- Knowledge/Experience with quality tools such as Trackwise 8, Veeva, eCTD viewer
- Good knowledge of FDA, EMA, ICH regulations and quality system standards
- Experience as a Change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory/quality standards
- Work in a controlled environment requiring special gowning and protective clothing
- Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails
- Work around chemicals such as alcohol, acids, buffers that may require respiratory protection
Tasks
- Prepare Product Quality Reviews (PQR) annually for products manufactured at the Neuchâtel facility
- Review global release specifications and implement updated versions for Neuchâtel products
- Participate in GMP tours to ensure inspection readiness
- Manage and prepare documentation for regulatory submissions and major change projects
- Prepare and review documentation for change controls, audit observations, and regulatory agency inquiries
- Support and write responses to regulatory agency questions, collaborating with Subject Matter Experts as needed
- Assist in the preparation of inspections and required documents
- Participate in audits and inspections as required
- Help define strategies for responses to health authority questions as part of the quality matrix team
- Update inspection records in TrackWise when necessary
- Propose initiatives to improve and streamline quality tasks
- Assist in the preparation and review of quality documentation as needed
- Participate in Quality Council meetings as necessary
- Support coordination of site Key Performance Indicators (KPIs)
- Participate in project teams based on expertise and project focus
- Engage in product launch activities
- Identify opportunities to enhance quality processes
- Collaborate with global Quality Product Leads and Regulatory Affairs partners
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- French – Business Fluent
Tools & Technologies
- Trackwise 8
- Veeva
- eCTD viewer
Benefits
More Vacation Days
- 28 days of paid time off
Healthcare & Fitness
- Sport/Fitness abonnement contribution
- Medical annual check-ups starting at age 50
- Financial support for preventive healthcare
Free or Subsidized Food
- On-site cafeteria
Generous Parental Leave
- Paid leave for maternity
- Paid leave for paternity
- Paid leave for adoption
Childcare
- Dedicated spaces for nursing mothers
Learning & Development
- Access to a Learning Catalog
- Language courses
Career Advancement
- Opportunities for internal mobility
Workation & Sabbatical
- Opportunities for international mobility
Public Transport Subsidies
- Contributions for public transport
Company Bike
- Incentives for e-biking
Parking & Commuter Benefits
- On-site charging stations for electric vehicles
Team Events
- Regular on-site gardening activities
Mental Health Support
- Regular on-site massages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Takeda
Industry
Pharmaceuticals
Description
Das Unternehmen fokussiert sich darauf, lebensverändernde Therapien in den Bereichen Magen-Darm- und Entzündungskrankheiten, seltene Krankheiten, Onkologie, Neurowissenschaften und Impfstoffe zu entdecken und bereitzustellen.
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