GMP Documentation Specialist | GMP-Spezialist in der Dokumentation (m/w/d)
PS Direkt GmbH Co. KG
Job Summary
This role involves supporting the operational manufacturing of cell therapeutics for a biotechnology company near Cologne. As a GMP Documentation Specialist, you will be responsible for the meticulous review and release of Batch Records in accordance with Good Manufacturing Practice (GMP) guidelines. You will act as a vital link between Quality Control, Quality Assurance, and Manufacturing departments to ensure documentation accuracy and timely processing. Your daily tasks include correcting batch records, managing error processing, and drafting or updating Standard Operating Procedures (SOPs). Additionally, you will oversee regular equipment inspections and maintain detailed documentation of these checks. This position is ideal for professionals who enjoy structured documentation and want to contribute to the field of cancer research. The role offers a modern technical environment, flexible working hours through a flextime model, and the stability of a permanent contract within an international company focused on life-saving medical advancements.
Required Skills
Education
Completed vocational training as a Biological Technical Assistant (BTA), Chemical Technical Assistant (CTA), Biology/Chemistry Laboratory Technician, or a comparable qualification.
Experience
- Professional experience as a Biological Technical Assistant (BTA), Chemical Technical Assistant (CTA), or Biology Laboratory Technician
- Practical experience working with Batch Records under GMP conditions is highly preferred
- Experience in error processing and correction of manufacturing documentation
- Proven ability to manage priorities and maintain process overviews in a regulated environment
Languages
Additional
- Location: Cologne area; Full-time, permanent position; Requires willingness to work in a highly regulated biotechnology environment.
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