Batch Record Reviewer
vor 3 Wochen
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are currently seeking a **Batch Record Reviewer (BRR) & Document Control Specialist** to join our growing team at Visp. In this role, you will be responsible for the review, tracking, and maintenance of critical production and process records in compliance with Good Manufacturing Practices (GMP). You will also support various administrative tasks related to document control and training, ensuring high standards are upheld.
**Key Responsibilities**:
- Perform second-tier Batch Record Reviews (BRR2) for process records, including Laboratory Information Management System (LIMS) reviews
- Maintain and update the BRR tracker for accurate tracking of documents and records
- Prepare Key Performance Indicator (KPI) reports and status updates for management
- Collect and organize data to support process validation and cleaning validation activities
- Review logbooks and protocols, ensuring completeness and accuracy, and facilitate the scanning and filing process
- Maintain and update the WIZU system for documentation and record control
- Process documents in the LQM system to ensure proper version control and compliance
- Monitor the shift training status of production teams to ensure compliance with training requirements
- Manage office tasks such as maintaining the signature list and controlling copies of SOPs and logbooks
**Skills and Attributes**:
- Proficiency in Microsoft Excel and Word
- Strong communication skills in English (German is an advantage)
- Collaborative team player with excellent interpersonal skills
- Detail-oriented, with a focus on accuracy and meeting deadlines
- Ability to work efficiently with various systems, including SAP, LIMS, DMS, Trackwise, MES, or any electronic batch execution management system
- Experience in a GMP-regulated environment is a plus
- Good understanding of Good Documentation Practice (GDP)
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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