New Job?Nejo!

The AI Job Search Engine

LI
Lilly Deutschland GmbH
2mo ago

Computer System Quality Assurance /Data Integrity Representative(m/w/x)

Alzey
Full-timeOn-siteSenior

Description

In this role, you will ensure the quality and compliance of computer systems at the Lilly Alzey site, collaborating with global teams and overseeing projects from design to implementation. Your work will be crucial in maintaining high standards and supporting the launch of innovative healthcare solutions.

Let AI find the perfect jobs for you!

Upload your CV and Nejo AI will find matching job offers for you.

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

Education

Bachelor's degree

Work Experience

5 years

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

Tools & Technologies

GMP computer systemsSAP

Languages

English – Business Fluent

German – Basic

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.
Not a perfect match?
100+ Similar Jobs in Alzey
  • 350 Lilly Deutschland GmbH

    Senior Quality Associate, Parenteral(m/w/x)

    Full-timeOn-siteSenior
    Alzey
  • 350 Lilly Deutschland GmbH

    Senior Assistant, Quality Assurance – Document Control(m/w/x)

    Full-timeOn-siteSenior
    Alzey
  • 350 Lilly Deutschland GmbH

    Senior Engineer, Quality Assurance - Facilities, Utilities, Maintenance, Engineering(m/w/x)

    Full-timeOn-siteSenior
    Alzey
  • 350 Lilly Deutschland GmbH

    Senior Manager - Quality Control Environmental Monitoring(m/w/x)

    Full-timeOn-siteManagement
    Wiesbaden, Alzey
  • 350 Lilly Deutschland GmbH

    Associate Director TSMS Sterility Assurance(m/w/x)

    Full-timeOn-siteManagement
    Alzey
100+ View all similar jobs
Apply now