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Quality Assurance Specialist(m/w/x)
GMP-compliant manufacturing oversight for parenteral pharmaceutical products at a global health and agriculture company. Licensed pharmacist with initial experience in drug risk assessment and regulations required. Company daycare centers, childcare support.
Requirements
- Degree in pharmacy and licensed pharmacist
- Initial professional experience in pharmaceutical manufacturing, testing, or evaluation
- Strong understanding of drug risk assessment, national/international regulations, and GMP environment
- Proficiency in IT systems such as MS Office
- Ability to analyze technical processes and derive targeted measures
- Strong organizational and excellent communication skills
- Leadership qualities: independent work, assertiveness, communication, flexibility, resilience
- Strong focus on quality and cost awareness
- Fluency in German and good written/spoken English
Tasks
- Ensure GMP-compliant manufacturing of pharmaceutical products
- Collaborate with Production, QA, and QC teams
- Oversee pharmaceutical production facilities for parenteral products
- Adhere to GMP guidelines and pharmaceutical regulations
- Create and update pharmaceutical-related documents
- Prepare manufacturing instructions per Section 13 AMWHV
- Develop and maintain SOPs
- Conduct investigations for process deviations
- Prepare investigation reports with QA/QC
- Ensure validations of manufacturing processes
- Train production staff as per §12 AMWHV
- Initiate Change Control measures
- Review manufacturing records
- Handle customer complaints
- Manage inspection and audit preparations
- Follow up on inspections and audits
- Ensure GMP compliance in projects and processes
- Optimize GMP compliance for cost-effectiveness
- Supervise practical training of pharmacy interns per §4 AappO
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Bonuses & Incentives
- Variable compensation component
Flexible Working
- Flexible work models
- Part-time 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 and mentoring programs
Healthcare & Fitness
- Health checks
Informal Culture
- Inclusive work environment
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Quality Assurance Specialist(m/w/x)
GMP-compliant manufacturing oversight for parenteral pharmaceutical products at a global health and agriculture company. Licensed pharmacist with initial experience in drug risk assessment and regulations required. Company daycare centers, childcare support.
Requirements
- Degree in pharmacy and licensed pharmacist
- Initial professional experience in pharmaceutical manufacturing, testing, or evaluation
- Strong understanding of drug risk assessment, national/international regulations, and GMP environment
- Proficiency in IT systems such as MS Office
- Ability to analyze technical processes and derive targeted measures
- Strong organizational and excellent communication skills
- Leadership qualities: independent work, assertiveness, communication, flexibility, resilience
- Strong focus on quality and cost awareness
- Fluency in German and good written/spoken English
Tasks
- Ensure GMP-compliant manufacturing of pharmaceutical products
- Collaborate with Production, QA, and QC teams
- Oversee pharmaceutical production facilities for parenteral products
- Adhere to GMP guidelines and pharmaceutical regulations
- Create and update pharmaceutical-related documents
- Prepare manufacturing instructions per Section 13 AMWHV
- Develop and maintain SOPs
- Conduct investigations for process deviations
- Prepare investigation reports with QA/QC
- Ensure validations of manufacturing processes
- Train production staff as per §12 AMWHV
- Initiate Change Control measures
- Review manufacturing records
- Handle customer complaints
- Manage inspection and audit preparations
- Follow up on inspections and audits
- Ensure GMP compliance in projects and processes
- Optimize GMP compliance for cost-effectiveness
- Supervise practical training of pharmacy interns per §4 AappO
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Bonuses & Incentives
- Variable compensation component
Flexible Working
- Flexible work models
- Part-time 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 and mentoring programs
Healthcare & Fitness
- Health checks
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 Specialist:in(m/w/x)
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