350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
LILilly Deutschland GmbH
Computer System Quality Assurance /Data Integrity Representative(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP computer systems
- SAP
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP computer systems
- SAP
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lilly Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein globaler Marktführer im Gesundheitswesen mit Fokus auf die Entwicklung lebensverändernder Medikamente.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
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Associate Director TSMS Sterility Assurance(m/w/x)
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