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Ensuring GMP compliance for drug delivery forms at global manufacturer with 7,000+ products, leading a 100-person team. Degree in Pharmacy, Chemistry, or Biology, plus pharmaceutical regulatory compliance and management experience required. Application support for disability.
Requirements
- Degree in Pharmacy, Chemistry, or Biology
- Experience in pharmaceutical quality management
- Knowledge of GMP regulations and standards
- Experience in managing audits and inspections
- Understanding of pharmaceutical manufacturing processes
- Excellent leadership and people management skills
- Strategic thinking and problem-solving ability
- Strong communication in German and English
- High integrity and compliance orientation
- Ability to manage complex projects
- Strong customer focus and advisory skills
- Familiarity with digital quality systems
Tasks
- Lead a quality organization of nearly 100 employees
- Prioritize patient safety and product quality in all decisions
- Select, manage, and evaluate departmental staff
- Ensure compliance with international GMP and legal requirements
- Implement global quality policies into local processes
- Advise customers on quality-related matters and service
- Align departmental tasks with corporate economic objectives
- Meet annual operational revenue and performance targets
- Oversee testing of raw materials and finished pharmaceuticals
- Support process and cleaning validations with analytical data
- Prepare master orders and manufacturing documents
- Manage the release of bulk and finished products
- Coordinate regulatory, customer, and supplier audits
- Conduct internal self-inspections and quality audits
- Manage complaints, deviations, and regulatory matters
- Maintain a quality reporting system for process improvement
- Oversee computer validation and equipment qualification
- Manage SOP systems and GMP training programs
- Optimize processes while maintaining legal compliance
- Share quality-related information across corporate sites
- Execute special projects assigned by leadership
Work Experience
- 5 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU GMP
- AMWHV
- 21 CFR 210/211
- Digital quality systems
- Process optimization tools
Benefits
Career Advancement
- Karrieremöglichkeiten
Other Benefits
- Bewerbungsunterstützung bei Behinderung
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Ensuring GMP compliance for drug delivery forms at global manufacturer with 7,000+ products, leading a 100-person team. Degree in Pharmacy, Chemistry, or Biology, plus pharmaceutical regulatory compliance and management experience required. Application support for disability.
Requirements
- Degree in Pharmacy, Chemistry, or Biology
- Experience in pharmaceutical quality management
- Knowledge of GMP regulations and standards
- Experience in managing audits and inspections
- Understanding of pharmaceutical manufacturing processes
- Excellent leadership and people management skills
- Strategic thinking and problem-solving ability
- Strong communication in German and English
- High integrity and compliance orientation
- Ability to manage complex projects
- Strong customer focus and advisory skills
- Familiarity with digital quality systems
Tasks
- Lead a quality organization of nearly 100 employees
- Prioritize patient safety and product quality in all decisions
- Select, manage, and evaluate departmental staff
- Ensure compliance with international GMP and legal requirements
- Implement global quality policies into local processes
- Advise customers on quality-related matters and service
- Align departmental tasks with corporate economic objectives
- Meet annual operational revenue and performance targets
- Oversee testing of raw materials and finished pharmaceuticals
- Support process and cleaning validations with analytical data
- Prepare master orders and manufacturing documents
- Manage the release of bulk and finished products
- Coordinate regulatory, customer, and supplier audits
- Conduct internal self-inspections and quality audits
- Manage complaints, deviations, and regulatory matters
- Maintain a quality reporting system for process improvement
- Oversee computer validation and equipment qualification
- Manage SOP systems and GMP training programs
- Optimize processes while maintaining legal compliance
- Share quality-related information across corporate sites
- Execute special projects assigned by leadership
Work Experience
- 5 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU GMP
- AMWHV
- 21 CFR 210/211
- Digital quality systems
- Process optimization tools
Benefits
Career Advancement
- Karrieremöglichkeiten
Other Benefits
- Bewerbungsunterstützung bei Behinderung
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Catalent
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Entwicklung von Darreichungsformen von Medikamenten und bietet über 7.000 Produkte an.
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Mitarbeiter Qualitätskontrolle(m/w/x)
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