Job
- Level
- Experienced
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Berlin, Kulmbach
- Working Model
- Onsite
Job Summary
In this role, you shape system validation in the GMP environment, take ownership of documentation and optimization of CSV processes, troubleshoot issues, and implement changes in a structured manner.
Job Technologies
Your role in the team
- Contribute your expertise in system validation and actively shape digital GMP processes as a QC Scientist (CSV).
- At the new production site, you will help establish quality control and work in a modern, growing environment with development opportunities.
- Design and manage validations of computer-based systems in a GMP environment.
- Take ownership of systems and ensure stability and availability.
- Analyze data accurately and troubleshoot issues efficiently.
- Create, maintain, and optimize CSV documentation and SOPs in accordance with current regulatory standards.
- Manage deviations, changes, and CAPAs in a structured manner and derive sustainable improvement measures.
- Support audits and continuously optimize processes and quality standards.
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Our expectations of you
Education
- Completed degree in Computer Science, Natural Sciences, Engineering, or a comparable qualification with practical experience.
Qualifications
- Excellent knowledge of CSV and proficient handling of LIMS, LabX, and Chromeleon.
- Ideally, knowledge of continuous process improvement (e.g., Lean, Six Sigma) and experience in leading (project) teams.
- Analytical, structured working style, high team spirit, as well as very good German and good English skills.
Experience
- Several years of experience in validation and quality management in the GxP environment.
- Experience with deviations, changes, and troubleshooting in a regulated environment.
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What we offer
- Structured onboarding and mentoring for a successful start.
- You have the unique opportunity to help establish our new location.
- Permanent employment contract, company pension scheme, and attractive employer contributions.
- Relocation assistance for candidates from outside the region.
- 30 days of annual leave.
- Subsidy for the Jobticket (Germany Ticket).
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Topics that you deal with on the job
Job Locations
This is your employer
LGC GmbH
LGC is a leading provider of laboratory services, measurement standards, reference materials, and proficiency testing. Our products and services help our customers to excel in investigative and diagnostic science, while also meeting international statutory and regulatory standards.
Description
- Founding year
- 1842
- Company Type
- Established Company
- Working Model
- Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
QC Scientist - System Validation & CSV
- Location
- Berlin, Kulmbach
- Working Model
- Onsite
- Diversity
- Open for all genders
