Quality Assurance Specialist
Vor 6 Tagen
About Lonza AG
Lonza AG is a global leader in life sciences, operating across three continents. Our company is built on the foundation of talented people working together to devise innovative solutions that help businesses improve people's lives.
Our Mission
We strive to be a trusted partner in the life sciences industry, providing high-quality products and services that meet the needs of our customers. Our team is dedicated to delivering exceptional results, and we are committed to making a positive impact on the world.
Job Summary
We are seeking a Quality Assurance Specialist - Batch Record Review to join our team at Lonza AG. As a key member of our quality team, you will be responsible for reviewing executed batch records, ensuring the completeness of documentation packages, and supporting the initiation of deviations and investigations.
Key Responsibilities
- Review executed batch records, including cleaning logs, production documentation, temperature reports, test procedures, raw data, and logbooks.
- Support batch release by ensuring the completeness of the documentation package.
- Review comments added to executed batch records, clarify with the operations team, and evaluate with the responsible QA Manager.
- Support the initiation of deviations and investigations for batch record review-related observations.
- Collect and evaluate KPI data on a regular basis.
- Write and revise SOPs in your area of expertise.
Requirements
- Bachelor's, Master's degree, or PhD in Biology, Chemistry, Biotechnology, Life Science, or a related field.
- Previous experience in GMP-regulated pharmaceutical or API industry is an advantage.
- Ability to identify non-compliance and gaps from quality standards.
- Structured, precise, and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated, and dynamic drive.
- German: Mother tongue or very proficient; English: Fluent.
What We Offer
At Lonza AG, we offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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