350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Full-timeOn-siteSenior
Alzey
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35350 Lilly Deutschland GmbH
Senior Assistant, Quality Assurance – Document Control(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
GMP Library document inventory control using Lilly Record Manager and Veeva Quality Docs EDMS for pharmaceutical products. 3 years pharma industry experience with EDMS/LRM and fluent English/German required. Excellent company pension plan, access to Corporate Lilly University.
Requirements
- High school diploma or equivalent
- Minimum 3 years in the pharmaceutical industry with document management experience
- On-site presence required
- Fluent in English and German
- Experience with Microsoft Office (Outlook, Word, Excel)
- Previous experience in records management, data entry, or similar
- Ability to work successfully in a team environment
- Project Management skills
- Strong written and verbal communication skills
- Strong problem-solving and decision-making ability
- Experience with documentation in a GMP environment and electronic tracking
- Experience in quality systems such as Veeva Vault QualityDocs
Tasks
- Maintain GMP Library document inventory control using the Lilly Record Manager (LRM) system
- Create and run semi-annual reports in LRM to check inventory as a Record Administrator (RA)
- Manage all documents and records in the Veeva Quality Docs Electronic Document Management System (EDMS)
- Ensure compliance with global and local Documentation and Records Management requirements
- Create, update, and route documents for review and approval in the EDMS
- Support functions with the creation, update, routing, review, and approval of electronic documents
- Manage and monitor assigned Veeva Vault QualityDocs workflows
- Meet with internal personnel to review documents and assign Veeva Quality Docs metadata
- Manage retention of GMP-related records according to Document Type and Record Class Codes (RCC)
- Facilitate the shipment of GMP records to external storage for long-term retention as needed
- Manage controlled print of GMP forms and facilitate the reconciliation process for executable records
- Support external and internal audits by providing accessible records for review
- Assist with Site Self Inspections related to Document Control and the Veeva Vault Q Docs EDMS
- Monitor and ensure periodic reviews of documents in Veeva Vault QualityDocs are performed
- Follow up with document owners to ensure timely review and updates
- Collaborate with Quality, Learning and Development, and other functions to capture document needs
Work Experience
- 3 years
Education
- High school diploma
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
- Veeva Vault QualityDocs
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.
Not a perfect match?
- 350 Lilly Deutschland GmbH
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Full-timeOn-siteManagementAlzey
35350 Lilly Deutschland GmbH
Senior Assistant, Quality Assurance – Document Control(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
GMP Library document inventory control using Lilly Record Manager and Veeva Quality Docs EDMS for pharmaceutical products. 3 years pharma industry experience with EDMS/LRM and fluent English/German required. Excellent company pension plan, access to Corporate Lilly University.
Requirements
- High school diploma or equivalent
- Minimum 3 years in the pharmaceutical industry with document management experience
- On-site presence required
- Fluent in English and German
- Experience with Microsoft Office (Outlook, Word, Excel)
- Previous experience in records management, data entry, or similar
- Ability to work successfully in a team environment
- Project Management skills
- Strong written and verbal communication skills
- Strong problem-solving and decision-making ability
- Experience with documentation in a GMP environment and electronic tracking
- Experience in quality systems such as Veeva Vault QualityDocs
Tasks
- Maintain GMP Library document inventory control using the Lilly Record Manager (LRM) system
- Create and run semi-annual reports in LRM to check inventory as a Record Administrator (RA)
- Manage all documents and records in the Veeva Quality Docs Electronic Document Management System (EDMS)
- Ensure compliance with global and local Documentation and Records Management requirements
- Create, update, and route documents for review and approval in the EDMS
- Support functions with the creation, update, routing, review, and approval of electronic documents
- Manage and monitor assigned Veeva Vault QualityDocs workflows
- Meet with internal personnel to review documents and assign Veeva Quality Docs metadata
- Manage retention of GMP-related records according to Document Type and Record Class Codes (RCC)
- Facilitate the shipment of GMP records to external storage for long-term retention as needed
- Manage controlled print of GMP forms and facilitate the reconciliation process for executable records
- Support external and internal audits by providing accessible records for review
- Assist with Site Self Inspections related to Document Control and the Veeva Vault Q Docs EDMS
- Monitor and ensure periodic reviews of documents in Veeva Vault QualityDocs are performed
- Follow up with document owners to ensure timely review and updates
- Collaborate with Quality, Learning and Development, and other functions to capture document needs
Work Experience
- 3 years
Education
- High school diploma
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
- Veeva Vault QualityDocs
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
Senior Quality Associate, Parenteral(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager - Quality Control Environmental Monitoring(m/w/x)
Full-timeOn-siteManagementWiesbaden, Alzey - Lilly Deutschland GmbH
Computer System Quality Assurance /Data Integrity Representative(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager Microbiology Laboratory(m/w/x)
Full-timeOn-siteManagementAlzey