Beschreibung

In this role, you will lead the implementation of the LABS system, collaborating with various teams to optimize laboratory processes and ensure compliance. Your day-to-day responsibilities will include project planning, stakeholder engagement, and ongoing support to enhance operational excellence.

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

Tools & Technologien

Benefits