Beschreibung
We are looking for candidates in the area of quality control for the following openings as interim support:Head of Quality Control Pilot Facility iNeST which will lead and support the establishment of a new production facility in Rhein Main Area, Germany
The following conditions apply:
- Working remotely using a laptop (to ease collaboration and data transfer within the team), when the situation allows potentially working onsite in Rhein Main as well ·
- 1 FTE for each position ·
- Duration: 12 months with flexible options for early termination or further extension
- Start: immediately
Task and responsibilities „Head of Quality Control Pilot Facility iNeST"
- Establish a quality control unit for commercial manufacturing of personalized drug products for EU and US as well as support technology transfers. ·
- Establish electronic and automated analytical work flows ·
- Establish a team of quality control operators, line managers and scientists. Work together with relevant departments like Quality Assurance, Manufacturing, Development and external partners ·
- Assess analytical results and approve CoAs for the release of patient individualized medicinal products. ·
- Responsible to evaluate and process quality relevant documents like deviations, changes, OOX. Responsible to represent the quality control unit in audits and inspections.
Competencies and Experience „Head of Quality Control Pilot Facility iNeST"
- Experienced in establishing and leading a quality control unit, preferably in the field of ATMPs. Experience in the relevant regulations. ·
- Experienced in establishing LIMS and automated analytical work flows ·
- Excellent communication skills in English and German