Our client is a privately held biotechnology and radio-pharmaceutical group that develops, manufactures and markets worldwide targeted diagnostic and therapeutic radio-pharmaceuticals and radioisotopes for the treatment of cancer.
Your tasks in detail are:
* Planning and implementation of technical qualifications and re-qualifications of process systems and rooms, including the creation of the necessary qualification documents (plans, protocols and reports on DQ-IQ-OQ-PQ for processes and production systems) as well as corresponding risk analyses in advance of the qualification measures
* Participation in the creation of necessary specifications and specifications in the context of new procurement
* GMP-compliant documentation of the work carried out
* Creation of qualification reports
* Participation in the review process of the respective qualification levels
* Participation in the planning and implementation of process validations and associated risk analyses
* Planning and implementation of process validations
* Evaluation and documentation of raw and measurement data as part of the validation measures
* Processing of changes and deviations
* Maintenance and archiving of documents
Your Qualifications:
* Experience in the area of qualification of systems / validation of processes in the pharmaceutical industry
* Successfully completed degree in engineering (process engineering, pharmaceutical or chemical engineering, pharmacy) or comparable training
* Good knowledge of GMP guidelines and common industry standards
* Several years of professional experience in the pharmaceutical industry desirable
* Independent and careful way of working
* High comprehension and willingness to work
* Communication skills and assertiveness
* Very good knowledge of spoken and written German and English
