350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Full-timeOn-siteSenior
Alzey
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LILilly Deutschland GmbH
Computer System Quality Assurance /Data Integrity Representative(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Assuring computer system compliance in global facility delivery, reviewing project documents for life-changing medicines. 5+ years in pharma/med device QA/CSV roles, with GMP computer systems validation proficiency required. Excellent company pension plan.
Requirements
- Bachelor's degree in engineering, computers, or science-related field
- At least 5 years working in pharmaceutical or medical device industry in QA or CSV roles
- Previous CSQA / CSV experience
- Proficiency with GMP computer systems validation
- Strong oral and written communication skills
- Strong technical writing skills
- Accountability for maintaining a safe work environment
- Ability to recognize and escalate potential long-term risks
- Fluent in English
- Proficiency in German is a plus
- Previous facility or area start-up experience
- Previous experience with SAP or other inventory management systems
- Short duration assignment of 1-3 weeks in another site may be required
Tasks
- Function as a CSQA with Global Facility Delivery and project staff
- Coordinate design and startup activities with global and project teams
- Provide technical and quality review of project computer system documents
- Ensure compliance with Lilly Global Quality Standards
- Assure computer systems are developed and maintained according to standards
- Provide quality oversight throughout the computer systems lifecycle
- Review and approve IT and Automation systems documents
- Manage CSQA priorities and schedules for timely delivery
- Assist with Data Integrity projects for the Alzey site
- Participate in Audit Trail Review of Computer Systems
- Conduct DI Assessment of Computer Systems to identify data vulnerabilities
- Support technical capability building for cross-functional staff
- Foster a strong quality culture through open communication and teamwork
- Establish partnerships with Technology Team and system owners
- Resolve or escalate compliance issues as necessary
- Support QA Compliance team in executing the site readiness plan
- Participate in self-led inspections and support regulatory inspections
- Review and redline documents to ensure quality attributes are met
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP computer systems
- SAP
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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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LILilly Deutschland GmbH
Computer System Quality Assurance /Data Integrity Representative(m/w/x)
Alzey
Full-timeOn-siteSenior
Nejo AI Summary
Assuring computer system compliance in global facility delivery, reviewing project documents for life-changing medicines. 5+ years in pharma/med device QA/CSV roles, with GMP computer systems validation proficiency required. Excellent company pension plan.
Requirements
- Bachelor's degree in engineering, computers, or science-related field
- At least 5 years working in pharmaceutical or medical device industry in QA or CSV roles
- Previous CSQA / CSV experience
- Proficiency with GMP computer systems validation
- Strong oral and written communication skills
- Strong technical writing skills
- Accountability for maintaining a safe work environment
- Ability to recognize and escalate potential long-term risks
- Fluent in English
- Proficiency in German is a plus
- Previous facility or area start-up experience
- Previous experience with SAP or other inventory management systems
- Short duration assignment of 1-3 weeks in another site may be required
Tasks
- Function as a CSQA with Global Facility Delivery and project staff
- Coordinate design and startup activities with global and project teams
- Provide technical and quality review of project computer system documents
- Ensure compliance with Lilly Global Quality Standards
- Assure computer systems are developed and maintained according to standards
- Provide quality oversight throughout the computer systems lifecycle
- Review and approve IT and Automation systems documents
- Manage CSQA priorities and schedules for timely delivery
- Assist with Data Integrity projects for the Alzey site
- Participate in Audit Trail Review of Computer Systems
- Conduct DI Assessment of Computer Systems to identify data vulnerabilities
- Support technical capability building for cross-functional staff
- Foster a strong quality culture through open communication and teamwork
- Establish partnerships with Technology Team and system owners
- Resolve or escalate compliance issues as necessary
- Support QA Compliance team in executing the site readiness plan
- Participate in self-led inspections and support regulatory inspections
- Review and redline documents to ensure quality attributes are met
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP computer systems
- SAP
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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
Lilly Deutschland GmbH
Industry
Healthcare
Description
Das Unternehmen ist ein globaler Marktführer im Gesundheitswesen mit Fokus auf die Entwicklung lebensverändernder Medikamente.
Not a perfect match?
- 350 Lilly Deutschland GmbH
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Senior Manager - Quality Control Environmental Monitoring(m/w/x)
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