Lilly
Senior Manager - Qualitätssicherung - Device Assembly and Packaging(m/w/x)
Full-timeOn-siteSenior
Alzey
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35350 Lilly Deutschland GmbH
Senior Quality Scientist, Device Assembly and Packaging(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring quality systems and GMP compliance for the final production of life-changing medicines, acting as process team contact. Five years pharmaceutical QA experience and German fluency required. Work in an advanced technology production facility.
Requirements
- Degree in science, engineering, pharmaceutical-related field or equivalent
- Five years pharmaceutical Quality Assurance experience
- Understanding of cGMP regulations and compliance
- Fluency in English and German
- On-site presence
- Experience in pharmaceutical manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan regulations
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal and teamwork skills
- Root cause analysis and troubleshooting skills
- Attention to detail and quality maintenance
- Ability to work independently or together
- Technical writing and communication skills
- Computer System Quality Assurance experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or electronic validation software
Tasks
- Maintain a safe work environment and lead safety initiatives
- Mentor and coach personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Act as the Quality point of contact for the process team
- Assess and triage deviations within the local process team
- Resolve product issues with support groups and external partners
- Support regulatory inspections and participate in self-led audits
- Review and approve quality documents and technical studies
- Participate in continuous improvement projects to boost productivity
- Approve validation documents for computer systems and equipment
- Benchmark best practices with Global Parenteral Network sites
- Provide guidance on non-conformance investigations and change controls
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- C&Q
- Validation oversight
- Computer systems validation
- Manufacturing Execution Systems
- KNEAT
- Electronic validation software
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Advanced technology production facility
Informal Culture
- Creative freedom
Career Advancement
- Individual career development
Learning & Development
- Professional development worldwide
Ergonomic Workplace
- Workplace accommodation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
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35350 Lilly Deutschland GmbH
Senior Quality Scientist, Device Assembly and Packaging(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring quality systems and GMP compliance for the final production of life-changing medicines, acting as process team contact. Five years pharmaceutical QA experience and German fluency required. Work in an advanced technology production facility.
Requirements
- Degree in science, engineering, pharmaceutical-related field or equivalent
- Five years pharmaceutical Quality Assurance experience
- Understanding of cGMP regulations and compliance
- Fluency in English and German
- On-site presence
- Experience in pharmaceutical manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan regulations
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal and teamwork skills
- Root cause analysis and troubleshooting skills
- Attention to detail and quality maintenance
- Ability to work independently or together
- Technical writing and communication skills
- Computer System Quality Assurance experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or electronic validation software
Tasks
- Maintain a safe work environment and lead safety initiatives
- Mentor and coach personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Act as the Quality point of contact for the process team
- Assess and triage deviations within the local process team
- Resolve product issues with support groups and external partners
- Support regulatory inspections and participate in self-led audits
- Review and approve quality documents and technical studies
- Participate in continuous improvement projects to boost productivity
- Approve validation documents for computer systems and equipment
- Benchmark best practices with Global Parenteral Network sites
- Provide guidance on non-conformance investigations and change controls
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- C&Q
- Validation oversight
- Computer systems validation
- Manufacturing Execution Systems
- KNEAT
- Electronic validation software
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Advanced technology production facility
Informal Culture
- Creative freedom
Career Advancement
- Individual career development
Learning & Development
- Professional development worldwide
Ergonomic Workplace
- Workplace accommodation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
350 Lilly Deutschland GmbH
Industry
Pharmaceuticals
Description
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Not a perfect match?
- Lilly
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