New Job?Nejo!

Your personal AI career agent

LILilly Deutschland GmbH

4mo ago

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.

Like this job?

Beta

Your Career Agent finds similar jobs for you every day.

Not a perfect match?

100+ Similar Jobs in Alzey View all

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
Data Engineer(m/w/x)
Full-timeOn-siteExperienced
Alzey
350 Lilly Deutschland GmbH
Senior Engineer, Quality Assurance - Facilities, Utilities, Maintenance, Engineering(m/w/x)
Full-timeOn-siteSenior
Alzey
350 Lilly Deutschland GmbH
Associate Director TSMS Sterility Assurance(m/w/x)
Full-timeOn-siteManagement
Alzey

View all 100+ similar jobs

LILilly Deutschland GmbH

4mo ago