Head of Quality Control (RE-33466659) Rheinland
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.
- 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
zur Vakanz
Weitere Jobs von Aplitrak