- Planning and coordinating qualification activities for lab equipment in compliance with current GMP and regulatory standards
- Executing change control records related to equipment lifecycle management
- Developing detailed qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, IOPQ protocols, decommissioning documents)
- Creating procedures (WIs, SOPs) related to equipment lifecycle management
- Installing, configuring, testing, and maintaining application software and system management tools
- Defining requirements for new software applications, analyzing process and data flow, and creating corresponding flowcharts
- Managing security, backup, and recovery strategies for databases and other data systems
- Providing operational support for QC and R&D labs
- Troubleshooting and resolving software-related issues
- Investigating deviations caused by nonconforming software, and implementing solutions (CAPA)
- Collaborating with vendors and IT personnel for issue resolution
- Strong communication skills
- Project management experience
- Proficiency in Microsoft Office programs (Outlook, Word, Excel, PowerPoint)
- Hands-on experience in instrument or software qualification and documentation (e.g., CSV, qualification of production plants, laboratory equipment)
- Knowledge of databases, networks (LAN, WAN), and patch management
- Strong analytical and problemsolving abilities
- Familiarity with virtualization (e.g., VMware, Virtual Box)
- Experience with TrackWise, SAP, and TruVault is advantageous
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Specialist Data Integrity - Schaffhausen, Schweiz - Johnson & Johnson
Beschreibung
Job Description:
At Johnson & Johnson, we strongly believe that health is of utmost importance.
Our expertise in healthcare innovation allows us to envision a world where we can prevent, treat, and even eradicate complex diseases, where treatments are more advanced and less invasive, and where solutions are tailored to each person.
Cilag AG is a prominent international manufacturing firm within the Janssen pharmaceutical division of the Johnson & Johnson Group. It specializes in producing pharmaceuticals, medical devices, and active pharmaceutical ingredients (APIs) for the global market at its facility in Schaffhausen.
Renowned for its innovative products, processes, and technologies, Cilag AG stands out as one of the top pharmaceutical companies in Switzerland and serves as a strategic hub for launching new products.
The Quality Control (QC) department is currently seeking a committed Specialist in Data Integrity / CSV (m/w/d, 80-100%) in Schaffhausen (Switzerland) to join their team at the earliest convenience or by mutual agreement.
In this role, you will work with a team passionate about introducing cutting-edge laboratory equipment, enhancing lab automation, and implementing improved software solutions.
You will be part of the Lab Services department in Site Quality Control, where you will oversee the lifecycle management of laboratory equipment.
Joining the newly established Data Governance & Lab Automation team, your primary responsibilities will involve qualifying laboratory equipment and software solutions.
Additionally, you will play a key role in investigating instrument and software-related issues, implementing necessary corrective and preventive actions.
If you are enthusiastic about enhancing patient safety through the introduction of new lab equipment, optimizing lab automation, and developing strategies to ensure data integrity, then we are eager to meet you.
Key Responsibilities:
Qualifications:
Education:
MSc / BSc degree in Natural Sciences, Computer Science, Engineering, or equivalent training with significant professional experience
Experience and Skills:
Languages:
Fluent in German and English
Preferred Qualifications:
Job Field:
Quality Control
Organization: Cilag AG (8562)
