Beschreibung

In this role, you will play a vital part in establishing a new QC lab, ensuring the release of life-saving medicines through rigorous testing and documentation. Daily tasks will involve executing tests, supporting validation activities, and contributing to quality documentation.

Anforderungen

• •Extensive work experience in Quality Control in GMP environment
• •Solid hands-on experience with ELISA, including method validation and method transfer in GMP environment
• •Experience with HPLC, iCIEF, PH, UV-VIS, osmolality
• •Apprenticeship as Lab technician, Bachelor, Master or equivalent in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• •Knowledge of lab quality systems like LIMS, Tiamo or CDS like Empower/Chromeleon
• •Fluency in written and spoken English, German is an asset
• •Ability to work independently and in a dynamic & fast-paced project environment
• •Proactive attitude

Aufgaben

• •Execute and coordinate physico-chemical and biochemical testing for Drug Product release and stability
• •Document assay execution following Good Documentation Practices under cGMP
• •Flag relevant observations for supervisor assessment
• •Prepare mobile phases and calibrate equipment in the lab
• •Maintain adherence to 6S and manage consumables
• •Support equipment maintenance activities
• •Assist in validation and transfer activities for new project introductions
• •Contribute to troubleshooting and investigation for assigned tasks
• •Author cGMP documents, including procedures and quality records

Tools & Technologien

Benefits