Tasks :

• Receives incoming documents (e.g. executed batch records, work orders, vendor labels, packaging instructions etc.). Performs documentation in respective tools. Prepares documentation needed for the batch record review (e.g. Analysis Reports, Specifications for clinical development, country label approval etc.)

• Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.

• Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels,... Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility (e.g. CoC's, BRR Checklists)

• Scan, file and archive documents owned by QA (e.g. Certificate of Compliance, Batch Record Review Checklists)

• Write and review procedures and forms related to the QA Batch record Review Process

• Contributes to Right First Time performance reports for release of IMPs

• Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes

• Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes

Qualification:

• Technician or Bachelor ( 3 years’ experience)

• Fluent in site language German and English required (adequate knowledge oral & written)

• Communication skills to sufficiently address GMP and logistic related questions with line unit experts

• Scientific, technical and regulatory knowledge in a specific area. Basic knowledge of drug development

• Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines

• Good organizational skills

Start : 01.06.2025