CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Neuenburg
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TATakeda
Product Quality Expert(m/w/x)
Neuenburg
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
Tools & Technologien
- Trackwise 8
- Veeva
- eCTD viewer
Benefits
Mehr Urlaubstage
- 28 days of paid time off
Gesundheits- & Fitnessangebote
- Sport/Fitness abonnement contribution
- Medical annual check-ups starting at age 50
- Financial support for preventive healthcare
Gratis oder Vergünstigte Mahlzeiten
- On-site cafeteria
Großzügige Elternzeit
- Paid leave for maternity
- Paid leave for paternity
- Paid leave for adoption
Kinderbetreuung
- Dedicated spaces for nursing mothers
Weiterbildungsangebote
- Access to a Learning Catalog
- Language courses
Karriere- und Weiterentwicklung
- Opportunities for internal mobility
Workation & Sabbatical
- Opportunities for international mobility
Öffi Tickets
- Contributions for public transport
Firmenfahrrad
- Incentives for e-biking
Parkplatz & Pendelvorteile
- On-site charging stations for electric vehicles
Team Events & Ausflüge
- Regular on-site gardening activities
Mentale Gesundheitsförderung
- Regular on-site massages
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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TATakeda
Product Quality Expert(m/w/x)
Neuenburg
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
Tools & Technologien
- Trackwise 8
- Veeva
- eCTD viewer
Benefits
Mehr Urlaubstage
- 28 days of paid time off
Gesundheits- & Fitnessangebote
- Sport/Fitness abonnement contribution
- Medical annual check-ups starting at age 50
- Financial support for preventive healthcare
Gratis oder Vergünstigte Mahlzeiten
- On-site cafeteria
Großzügige Elternzeit
- Paid leave for maternity
- Paid leave for paternity
- Paid leave for adoption
Kinderbetreuung
- Dedicated spaces for nursing mothers
Weiterbildungsangebote
- Access to a Learning Catalog
- Language courses
Karriere- und Weiterentwicklung
- Opportunities for internal mobility
Workation & Sabbatical
- Opportunities for international mobility
Öffi Tickets
- Contributions for public transport
Firmenfahrrad
- Incentives for e-biking
Parkplatz & Pendelvorteile
- On-site charging stations for electric vehicles
Team Events & Ausflüge
- Regular on-site gardening activities
Mentale Gesundheitsförderung
- Regular on-site massages
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Takeda
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen fokussiert sich darauf, lebensverändernde Therapien in den Bereichen Magen-Darm- und Entzündungskrankheiten, seltene Krankheiten, Onkologie, Neurowissenschaften und Impfstoffe zu entdecken und bereitzustellen.
Noch nicht perfekt?
- CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Bristol Myers Squibb
C&Q Engineer(m/w/x)
Vollzeitnur vor OrtJuniorBoudry - Bristol Myers Squibb
Metrology Intern – Specialist Documentation & Data Management(m/w/x)
VollzeitPraktikumnur vor OrtBoudry - CHE - 8262 Baxalta Manufacturing Sarl
Senior Operational Excellence Champion - Lean Black Belt(m/w/x)
Vollzeitnur vor OrtSeniorNeuenburg - Jabil Switzerland Manufacturing GmbH
Laboratory Technician - Sterility Assurance(m/w/x)
Vollzeitnur vor OrtKeine AngabeLe Locle