QA Associate
Vor 3 Tagen
Your main duties as a QA Associate will include:
- Supporting the timely release of GMP relevant documents and batches and support adherence to compliance with cGMP in TRD.
- Receiving incoming documents, including executed batch records, work orders, vendor labels, packaging instructions.
- Performing documentation needed for the batch record review, including Analysis Reports, Specifications for clinical development, and country label approval.
Additional duties will include:
- Writing and reviewing procedures and forms related to the QA Batch record Review Process.
- Contributing to Right First Time performance reports for release of IMPs.
- Supporting and collaborating with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes.
- Supporting the use, improvement, evaluation and implementation of GMP relevant IT tools and processes.
Your Background:
- Technician (10 years’ experience) or Bachelor (5 years’ experience).
- Fluent in site language German, as well as 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.
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