PAION Pharma GmbH
Associate Director Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSenior
Aachen
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
PAPAION Pharma GmbH
Production Manager Pharma for Commercial API and Drug Product(m/w/x)
Aachen
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
SME for API and drug product manufacturing, managing CMO interactions and GMP compliance. 5+ years in pharma/biotech with sterile injectables experience required. 30 days vacation, short communication channels.
Anforderungen
- Postgraduate/graduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Science
- At least 5 years in pharmaceutical or biotechnology industry
- Experience in API manufacturing, drug product manufacturing (steriles and injectables preferred), process chemistry, process development and validation, and manufacturing process lifecycle management
- Deep knowledge of GMP, ICH requirements, and EU/US requirements
- Proven knowledge of commercial manufacturing and on-time manufacture of APIs/drug products as technical expert with QA team
- Proven knowledge of managing change controls and deviations
- Proven knowledge of process validation
- Beneficial experience in technical management and direction of external vendors
- Beneficial experience in manufacturing of sterile products/injectables
- Knowledge of national regulatory requirements for Asian countries (Japan, Korea, China)
Aufgaben
- Become SME for API and drug product manufacturing
- Manage interaction with CMOs for API and drug product manufacture
- Review manufacturing documentation and Master Batch Records
- Ensure manufacturing is on-time and follows GMP guidelines
- Ensure manufacturing follows ICH requirements
- Ensure manufacturing follows PAION specifications and procedures
- Manage production-related change controls
- Manage production-related deviations
- Manage validation reports
- Manage risk assessments
- Perform Life Cycle Management of manufacturing processes
- Support Life Cycle Management of manufacturing processes
- Perform Continuous Improvement of manufacturing processes
- Support Continuous Improvement of manufacturing processes
- Perform process validation activities
- Review manufacturing processes
- Update manufacturing processes
- Improve manufacturing processes
- Incorporate EU GMP guideline updates into processes
- Incorporate other territory GMP guideline updates into processes
- Provide SME support to licensees on production topics
- Organize manufacturing process transfer programs
- Support manufacturing process transfer programs
- Provide technical support for registration documentation
- Maintain registration documentation
- Provide SME expertise for manufacturing facility audits
- Ensure audits follow GMP
- Ensure audits follow current guidelines
- Ensure audits follow internal procedures
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- 30 days vacation
Lockere Unternehmenskultur
- Short communication channels
- Open doors
- Helpful colleagues
- Committed colleagues
Flexibles Arbeiten
- Flexible working hours
- Partial home office
- Work-life balance
Gesundheits- & Fitnessangebote
- Supplementary health insurance
Betriebliche Altersvorsorge
- Pension scheme
Modernes Büro
- Modern office building
Parkplatz & Pendelvorteile
- Underground parking
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PAION Pharma GmbH 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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PAPAION Pharma GmbH
Production Manager Pharma for Commercial API and Drug Product(m/w/x)
Aachen
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
SME for API and drug product manufacturing, managing CMO interactions and GMP compliance. 5+ years in pharma/biotech with sterile injectables experience required. 30 days vacation, short communication channels.
Anforderungen
- Postgraduate/graduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Science
- At least 5 years in pharmaceutical or biotechnology industry
- Experience in API manufacturing, drug product manufacturing (steriles and injectables preferred), process chemistry, process development and validation, and manufacturing process lifecycle management
- Deep knowledge of GMP, ICH requirements, and EU/US requirements
- Proven knowledge of commercial manufacturing and on-time manufacture of APIs/drug products as technical expert with QA team
- Proven knowledge of managing change controls and deviations
- Proven knowledge of process validation
- Beneficial experience in technical management and direction of external vendors
- Beneficial experience in manufacturing of sterile products/injectables
- Knowledge of national regulatory requirements for Asian countries (Japan, Korea, China)
Aufgaben
- Become SME for API and drug product manufacturing
- Manage interaction with CMOs for API and drug product manufacture
- Review manufacturing documentation and Master Batch Records
- Ensure manufacturing is on-time and follows GMP guidelines
- Ensure manufacturing follows ICH requirements
- Ensure manufacturing follows PAION specifications and procedures
- Manage production-related change controls
- Manage production-related deviations
- Manage validation reports
- Manage risk assessments
- Perform Life Cycle Management of manufacturing processes
- Support Life Cycle Management of manufacturing processes
- Perform Continuous Improvement of manufacturing processes
- Support Continuous Improvement of manufacturing processes
- Perform process validation activities
- Review manufacturing processes
- Update manufacturing processes
- Improve manufacturing processes
- Incorporate EU GMP guideline updates into processes
- Incorporate other territory GMP guideline updates into processes
- Provide SME support to licensees on production topics
- Organize manufacturing process transfer programs
- Support manufacturing process transfer programs
- Provide technical support for registration documentation
- Maintain registration documentation
- Provide SME expertise for manufacturing facility audits
- Ensure audits follow GMP
- Ensure audits follow current guidelines
- Ensure audits follow internal procedures
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- 30 days vacation
Lockere Unternehmenskultur
- Short communication channels
- Open doors
- Helpful colleagues
- Committed colleagues
Flexibles Arbeiten
- Flexible working hours
- Partial home office
- Work-life balance
Gesundheits- & Fitnessangebote
- Supplementary health insurance
Betriebliche Altersvorsorge
- Pension scheme
Modernes Büro
- Modern office building
Parkplatz & Pendelvorteile
- Underground parking
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PAION Pharma GmbH 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
PAION Pharma GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein spezialisiertes Pharmaunternehmen im Bereich Anästhesie und Intensivpflege, das innovative Wirkstoffe für den Einsatz bei Patienten in Kliniken und ambulant entwickelt.
Noch nicht perfekt?
- PAION Pharma GmbH
Associate Director Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorAachen - Grünenthal GmbH
Global Operations Strategy Manager(m/w/x)
Vollzeitmit HomeofficeSeniorAachen - Grünenthal GmbH
Head Global Quality Excellence(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementAachen - DocMorris
Pharmazeutisch-technische Assistenten für die Rezeptur(m/w/x)
Vollzeitmit HomeofficeSeniorAachen - SGS
Chemiker:in / Projektleiter:in Pharma / Health Science(m/w/x)
Vollzeitmit HomeofficeJuniorAachen