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BP Regulatory Affairs Manager(m/w/x)
At a life-science company, authoring GxP documentation and training for pharmaceutical manufacturing, ensuring GMP customer alignment. Solid quality background with core GxP systems and pharma manufacturing experience required. Thirty vacation days, working time account, remote work across Germany.
Anforderungen
- Degree in natural science, biotechnology, or comparable
- Solid quality background with core GxP systems
- Professional experience in quality or regulatory in pharma manufacturing
- Professional experience with quality tools in pharmaceutical industry
- Excellent communication skills in German and English
- Accurate and detail-oriented mindset
- Highly skilled in Microsoft Office applications
- Passionated and motivating attitude
Aufgaben
- Author and maintain internal guidance and training documentation
- Collaborate with global functions, suppliers, and customers to share expertise
- Review documents for alignment with GMP customer expectations
- Provide targeted training sessions and participate in global presentations
- Work closely with the Quality team to align on quality systems
- Support colleagues in implementing requirements and translating them into solutions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GxP systems
- Computer software validation (CSV)
- Equipment qualification (IQ/OQ)
- Process Validation
Benefits
Mehr Urlaubstage
- Thirty vacation days per year
- Company-regulated special leave days
Flexibles Arbeiten
- Flexible flextime framework
- Working time account
- Remote work across Germany
Betriebliche Altersvorsorge
- Employer-funded retirement plans
Firmenfahrrad
- Job bike
Öffi Tickets
- Public transport subsidies
Mitarbeiterrabatte
- Corporate benefits
Weiterbildungsangebote
- Freely selectable training sessions
- Participation in conferences
- Access to learning platforms
Lockere Unternehmenskultur
- Diverse and open-minded work environment
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BP Regulatory Affairs Manager(m/w/x)
At a life-science company, authoring GxP documentation and training for pharmaceutical manufacturing, ensuring GMP customer alignment. Solid quality background with core GxP systems and pharma manufacturing experience required. Thirty vacation days, working time account, remote work across Germany.
Anforderungen
- Degree in natural science, biotechnology, or comparable
- Solid quality background with core GxP systems
- Professional experience in quality or regulatory in pharma manufacturing
- Professional experience with quality tools in pharmaceutical industry
- Excellent communication skills in German and English
- Accurate and detail-oriented mindset
- Highly skilled in Microsoft Office applications
- Passionated and motivating attitude
Aufgaben
- Author and maintain internal guidance and training documentation
- Collaborate with global functions, suppliers, and customers to share expertise
- Review documents for alignment with GMP customer expectations
- Provide targeted training sessions and participate in global presentations
- Work closely with the Quality team to align on quality systems
- Support colleagues in implementing requirements and translating them into solutions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GxP systems
- Computer software validation (CSV)
- Equipment qualification (IQ/OQ)
- Process Validation
Benefits
Mehr Urlaubstage
- Thirty vacation days per year
- Company-regulated special leave days
Flexibles Arbeiten
- Flexible flextime framework
- Working time account
- Remote work across Germany
Betriebliche Altersvorsorge
- Employer-funded retirement plans
Firmenfahrrad
- Job bike
Öffi Tickets
- Public transport subsidies
Mitarbeiterrabatte
- Corporate benefits
Weiterbildungsangebote
- Freely selectable training sessions
- Participation in conferences
- Access to learning platforms
Lockere Unternehmenskultur
- Diverse and open-minded work environment
Über das Unternehmen
DASGIP Information and Process Technology GmbH
Branche
Other
Beschreibung
Das Unternehmen bietet Gestaltungsspielraum in der Life-Science Branche und fördert ein wertschätzendes Arbeitsumfeld.
Noch nicht perfekt?
- DASGIP Information and Process Technology GmbH
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Vollzeitmit HomeofficeSeniorHückelhoven - Stadtwerke Jülich
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