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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU GMP Volume IV
- AMG
- CFRs
Benefits
Bonuses & Incentives
- Variable compensation component
Flexible Working
- Hybrid work models
- Part-time arrangements
- Flexible work arrangements
Childcare
- Company daycare centers
- Childcare support
- Summer camps for children
Family Support
- Time off for family care
Learning & Development
- Learning and development opportunities
- Training programs
Mentorship & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Healthcare & Fitness
- Health awareness promotion
- Free health checks
Mental Health Support
- Self-care opportunities
Informal Culture
- Inclusive work environment
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU GMP Volume IV
- AMG
- CFRs
Benefits
Bonuses & Incentives
- Variable compensation component
Flexible Working
- Hybrid work models
- Part-time arrangements
- Flexible work arrangements
Childcare
- Company daycare centers
- Childcare support
- Summer camps for children
Family Support
- Time off for family care
Learning & Development
- Learning and development opportunities
- Training programs
Mentorship & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Healthcare & Fitness
- Health awareness promotion
- Free health checks
Mental Health Support
- Self-care opportunities
Informal Culture
- Inclusive work environment
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Bayer
Industry
Pharmaceuticals
Description
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.
Not a perfect match?
- Bayer
Quality Assurance Manager:in - Premises & Equipment(m/w/x)
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Full-timeWith HomeofficeExperiencedLeverkusenfrom 77,300 - 93,800 / year - Semdor Pharma Group GmbH
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Senior Healthcare Quality Engineer(m/w/x)
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