350 Lilly Deutschland GmbH
Senior Quality Scientist, Device Assembly and Packaging(m/w/x)
Full-timeOn-siteSenior
Alzey
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35350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Quality oversight for manufacturing processes, non-conformance investigations, and batch disposition at a global pharmaceutical manufacturer. 5+ years pharma QA experience, cGMP understanding, and German fluency required. Access to Corporate Lilly University, excellent pension plan.
Requirements
- Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience
- Minimum 5 years in the pharmaceutical industry with Quality Assurance experience
- Understanding of cGMP regulations and practices
- Fluency in English and German
- On-site presence required
- Experience in parenteral manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan and other regulations in pharmaceutical manufacturing
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal skills and teamwork ability
- Root cause analysis and troubleshooting skills
- Attention to detail and quality systems maintenance
- Ability to work independently or as part of a team
- Technical writing and communication skills
- Computer System Quality Assurance (CSQA) experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or other electronic validation software
Tasks
- Provide daily oversight and guidance to the process team
- Advise on non-conformance investigations and change controls
- Support procedures, validations, and batch disposition
- Assist with commissioning and qualification activities
- Mentor and coach operations personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Serve as the Quality point of contact for the local process team
- Assess and triage deviations within the process team
- Collaborate with support groups and external partners on product issues
- Participate in self-led inspections and support regulatory inspections
- Initiate, review, and approve quality-related documents
- Engage in continuous improvement projects to enhance productivity
- Approve commissioning and validation documents for compliance
- Network with Global Parenteral Network sites to share best practices
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- KNEAT
- Manufacturing Execution Systems
- Computer System Quality Assurance
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Learning & Development
- Access to Corporate Lilly University
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.
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35350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Quality oversight for manufacturing processes, non-conformance investigations, and batch disposition at a global pharmaceutical manufacturer. 5+ years pharma QA experience, cGMP understanding, and German fluency required. Access to Corporate Lilly University, excellent pension plan.
Requirements
- Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience
- Minimum 5 years in the pharmaceutical industry with Quality Assurance experience
- Understanding of cGMP regulations and practices
- Fluency in English and German
- On-site presence required
- Experience in parenteral manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan and other regulations in pharmaceutical manufacturing
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal skills and teamwork ability
- Root cause analysis and troubleshooting skills
- Attention to detail and quality systems maintenance
- Ability to work independently or as part of a team
- Technical writing and communication skills
- Computer System Quality Assurance (CSQA) experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or other electronic validation software
Tasks
- Provide daily oversight and guidance to the process team
- Advise on non-conformance investigations and change controls
- Support procedures, validations, and batch disposition
- Assist with commissioning and qualification activities
- Mentor and coach operations personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Serve as the Quality point of contact for the local process team
- Assess and triage deviations within the process team
- Collaborate with support groups and external partners on product issues
- Participate in self-led inspections and support regulatory inspections
- Initiate, review, and approve quality-related documents
- Engage in continuous improvement projects to enhance productivity
- Approve commissioning and validation documents for compliance
- Network with Global Parenteral Network sites to share best practices
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- KNEAT
- Manufacturing Execution Systems
- Computer System Quality Assurance
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Learning & Development
- Access to Corporate Lilly University
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
Healthcare
Description
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Not a perfect match?
- 350 Lilly Deutschland GmbH
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Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Assistant, Quality Assurance – Document Control(m/w/x)
Full-timeOn-siteSeniorAlzey - Lilly Deutschland GmbH
Computer System Quality Assurance /Data Integrity Representative(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager - Quality Control Environmental Monitoring(m/w/x)
Full-timeOn-siteManagementWiesbaden, Alzey