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 activities will involve executing and reviewing testing methods, maintaining lab operations, and supporting new project validations.

Anforderungen

• •Solid work experience in cGMP controlled environment
• •Experience with iCIEF, CE-SDS, and basic phys/chem techniques (e.g. pH, UV-VIS, osmolality, HPLC) and understanding of current requirements and documentation
• •Experience with method validation and method transfer according to GMP
• •Apprenticeship as Lab technician, Bachelor 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 physico-chemical and biochemical Drug Product release testing
• •Review stability testing under cGMP following existing method SOPs
• •Document assay execution under cGMP and Good Documentation Practices
• •Flag relevant observations to the supervisor for assessment
• •Perform operational tasks in the lab, including mobile phase preparations
• •Calibrate equipment and maintain adherence to 6S standards
• •Manage consumables and support equipment maintenance
• •Contribute to validation and transfer activities for new projects
• •Assist in investigation and troubleshooting for assigned tasks

Tools & Technologien

Benefits