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Quality Assurance/Quality Control IT System Analyst(m/w/x)
Leading LABS implementation, configuration, and support for quality control systems at a global healthcare leader. 5+ years leading end-to-end projects in GMP environments with deep LABS platform knowledge required. Excellent company pension plan.
Anforderungen
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related field
- Minimum of 5+ years of LABS implementation experience in GMP regulated industry
- Experience with IT audits, compliance assessments, and remediation activities
- Deep knowledge and experience with LABS platforms
- Experience leading end-to-end LABS implementation projects in GMP environment
- Proficient in project management methodologies, such as Agile or Waterfall
- Expertise in integrating LABS systems with ERP and MES
- Knowledge of data management principles, including validation and reporting
- Strong understanding of Quality control processes in pharmaceutical industry
- Strong change management skills to drive organizational change
- Excellent communication and interpersonal skills
- Understanding of regulatory requirements in GMP
- Strong analytical and problem-solving skills
- Ability to troubleshoot system performance and data integrity problems
- Proven leadership abilities to lead cross-functional teams
- Understanding of cybersecurity concepts related to LABS technologies
- Adaptability and flexibility to work in a fast-paced environment
- Master’s degree in Computer Science, Information Technology, Business Administration, or related field preferred
- Exposure to international operations and global IT projects
- Proficiency in German and strong English language skills
- On-site presence required
Aufgaben
- Lead the LABS implementation process
- Gather requirements and design solutions
- Configure, test, and deploy LABS solutions
- Provide ongoing support for LABS system
- Analyze business needs with stakeholders
- Define functional requirements for LABS
- Develop and execute project plans
- Allocate resources and mitigate risks
- Build relationships with key stakeholders
- Ensure seamless adoption of LABS system
- Integrate LABS with existing systems
- Maintain data integrity and system reliability
- Develop training programs for end-users
- Create user guides and technical documentation
- Stay updated on industry trends and technologies
- Identify opportunities for process improvements
- Lead ongoing support and maintenance of LABS
- Translate technical concepts for diverse audiences
- Define and govern the LABS agenda
- Ensure compliance with industry regulations
- Develop comprehensive testing strategies
- Maintain data integrity and system configurations
- Support validation activities for LABS
- Collaborate with auditors for LABS inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- LABS
- ERP
- MES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Noch nicht perfekt?
- 350 Lilly Deutschland GmbHVollzeitnur vor OrtManagementAlzey
- 350 Lilly Deutschland GmbH
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Computer System Quality Assurance /Data Integrity Representative(m/w/x)
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Senior Assistant, Quality Assurance – Document Control(m/w/x)
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Quality Assurance/Quality Control IT System Analyst(m/w/x)
Leading LABS implementation, configuration, and support for quality control systems at a global healthcare leader. 5+ years leading end-to-end projects in GMP environments with deep LABS platform knowledge required. Excellent company pension plan.
Anforderungen
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related field
- Minimum of 5+ years of LABS implementation experience in GMP regulated industry
- Experience with IT audits, compliance assessments, and remediation activities
- Deep knowledge and experience with LABS platforms
- Experience leading end-to-end LABS implementation projects in GMP environment
- Proficient in project management methodologies, such as Agile or Waterfall
- Expertise in integrating LABS systems with ERP and MES
- Knowledge of data management principles, including validation and reporting
- Strong understanding of Quality control processes in pharmaceutical industry
- Strong change management skills to drive organizational change
- Excellent communication and interpersonal skills
- Understanding of regulatory requirements in GMP
- Strong analytical and problem-solving skills
- Ability to troubleshoot system performance and data integrity problems
- Proven leadership abilities to lead cross-functional teams
- Understanding of cybersecurity concepts related to LABS technologies
- Adaptability and flexibility to work in a fast-paced environment
- Master’s degree in Computer Science, Information Technology, Business Administration, or related field preferred
- Exposure to international operations and global IT projects
- Proficiency in German and strong English language skills
- On-site presence required
Aufgaben
- Lead the LABS implementation process
- Gather requirements and design solutions
- Configure, test, and deploy LABS solutions
- Provide ongoing support for LABS system
- Analyze business needs with stakeholders
- Define functional requirements for LABS
- Develop and execute project plans
- Allocate resources and mitigate risks
- Build relationships with key stakeholders
- Ensure seamless adoption of LABS system
- Integrate LABS with existing systems
- Maintain data integrity and system reliability
- Develop training programs for end-users
- Create user guides and technical documentation
- Stay updated on industry trends and technologies
- Identify opportunities for process improvements
- Lead ongoing support and maintenance of LABS
- Translate technical concepts for diverse audiences
- Define and govern the LABS agenda
- Ensure compliance with industry regulations
- Develop comprehensive testing strategies
- Maintain data integrity and system configurations
- Support validation activities for LABS
- Collaborate with auditors for LABS inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- LABS
- ERP
- MES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Über das Unternehmen
350 Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
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