Dein persönlicher KI-Karriere-Agent
Quality Assurance Manager - Premises & Equipment(m/w/x)
Ensuring production infrastructure quality and compliance for pharmaceutical manufacturing. EU GMP, CFRs, and validation expertise required. Hybrid work, variable compensation.
Anforderungen
- Completed scientific or engineering degree, or comparable extensive practical experience
- Proven leadership capabilities and ability to motivate
- In-depth know-how in EU GMP Volume IV, AMG, CFRs
- In-depth know-how in qualification and validation processes
- In-depth know-how in pharmaceutical documentation & data integrity
- In-depth know-how in technical fundamentals in GMP environment and engineering processes
- Enjoyment of working in a highly interconnected environment
- Strong communication and decision-making skills
- High reliability and quality awareness
- Ability to act confidently under pressure
- Fluent German at negotiation level
- Fluent English at negotiation level
Aufgaben
- Guarantee production infrastructure quality and compliance
- Oversee qualification, maintenance, and calibration of equipment
- Monitor global production capability according to regulatory requirements
- Review and approve qualification documents and risk analyses
- Evaluate deviations and CAPAs, create sustainable solutions
- Collaborate with production, QC, engineering, logistics, and cross-site teams
- Continuously improve processes and present during inspections
- Participate in Quality Management System development
- Drive training and improvement initiatives
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- EU GMP Volume IV
- AMG
- CFRs
Benefits
Boni & Prämien
- Variable compensation component
Flexibles Arbeiten
- Hybrid work models
- Part-time arrangements
- Flexible work arrangements
Kinderbetreuung
- Company daycare centers
- Childcare support
- Summer camps for children
Familienfreundlichkeit
- Time off for family care
Weiterbildungsangebote
- Learning and development opportunities
- Training programs
Mentoring & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Gesundheits- & Fitnessangebote
- Health awareness promotion
- Free health checks
Mentale Gesundheitsförderung
- Self-care opportunities
Lockere Unternehmenskultur
- Inclusive work environment
Gefällt dir diese Stelle?
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Quality Assurance Manager - Premises & Equipment(m/w/x)
Ensuring production infrastructure quality and compliance for pharmaceutical manufacturing. EU GMP, CFRs, and validation expertise required. Hybrid work, variable compensation.
Anforderungen
- Completed scientific or engineering degree, or comparable extensive practical experience
- Proven leadership capabilities and ability to motivate
- In-depth know-how in EU GMP Volume IV, AMG, CFRs
- In-depth know-how in qualification and validation processes
- In-depth know-how in pharmaceutical documentation & data integrity
- In-depth know-how in technical fundamentals in GMP environment and engineering processes
- Enjoyment of working in a highly interconnected environment
- Strong communication and decision-making skills
- High reliability and quality awareness
- Ability to act confidently under pressure
- Fluent German at negotiation level
- Fluent English at negotiation level
Aufgaben
- Guarantee production infrastructure quality and compliance
- Oversee qualification, maintenance, and calibration of equipment
- Monitor global production capability according to regulatory requirements
- Review and approve qualification documents and risk analyses
- Evaluate deviations and CAPAs, create sustainable solutions
- Collaborate with production, QC, engineering, logistics, and cross-site teams
- Continuously improve processes and present during inspections
- Participate in Quality Management System development
- Drive training and improvement initiatives
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- EU GMP Volume IV
- AMG
- CFRs
Benefits
Boni & Prämien
- Variable compensation component
Flexibles Arbeiten
- Hybrid work models
- Part-time arrangements
- Flexible work arrangements
Kinderbetreuung
- Company daycare centers
- Childcare support
- Summer camps for children
Familienfreundlichkeit
- Time off for family care
Weiterbildungsangebote
- Learning and development opportunities
- Training programs
Mentoring & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Gesundheits- & Fitnessangebote
- Health awareness promotion
- Free health checks
Mentale Gesundheitsförderung
- Self-care opportunities
Lockere Unternehmenskultur
- Inclusive work environment
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Bayer
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist entschlossen, die größten Herausforderungen unseres Planeten zu überwinden und zu einer Welt beizutragen, in der genug Nahrung und ausreichende medizinische Versorgung für alle Menschen erreichbar sind.
Noch nicht perfekt?
- Bayer
Quality Assurance Manager:in - Premises & Equipment(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeSeniorLeverkusenab 88.900 - 108.000 / Jahr - Bayer
Quality Assurance Manager - Pharmaceutical Solid Dosage Packaging(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenLeverkusenab 77.300 - 93.800 / Jahr - DEG FedEx Express Deutschland GmbH
Senior Healthcare Quality Engineer(m/w/x)
Vollzeitmit HomeofficeSeniorKöln - Semdor Pharma Group GmbH
QA/QC Manager(m/w/x)
Vollzeitmit HomeofficeSeniorKöln - Miltenyi Biotec
Qualification Validation Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBergisch Gladbach