You will actively handle the quality and compliance related issues especially related to equipment (Pipetting robot (TECAN), plate-reader etc.). Act as Subject Matter Expert (SME) during cGMP inspections and are responsible in planning and implementing these tools. You will have to create and maintain a long term (financial) plan for the equipment. Bring in new technologies and are responsible for automating of some of the pipetting work. You will be part of our team to maintain cGMP compliance and LEAN status of the team.
- The job holder coordinates activities related to equipment qualification and maintenance
- You are generating a long-term plan to meet future needs on required equipment (including financial plan) and follow up with stakeholders, making sure there is enough place and equipment to test future needs and that the lab lay-out is efficient to work in.
- The job holder is responsible for coordinating TECAN (pipetting robot) activities, making sure new scripts are being qualified and TECAN is most efficiently used.
- The job holder is responsible for setting-up URS’s (user requirement settings) in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
- You are connecting and scouting new technologies that could benefit the department. Checking and designing how the new technology could be implemented in the department within the GMP environment.
- Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines.
- The jobholder is responsible for ensuring that assays can technically be carried out by the departments concerned in a manner that is efficient, adheres to cGMP and is safe.
- Leads and drives continuous improvement processes.
- iLabs roll out in 2022 – coordination of digitalization of ASSAY run sheets in eLIMS (nice to have)
- Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions.
- Supervise timely closure of medium/high-level investigations and associated CPA’s.
- Supporting and advising other lead investigators from external and internal QC departments.
- Accurate lab investigation and CPA’s for the medium/high-level Quality issues.
- Good technical writing skill in English
- Knowledge of statistical data analyses
- Knowledge on equipment introduction
- Organizational skills in order to optimally coordinate a project, project management skills
- Experience in a GMP lab is a plus
- Experience with TECAN would be a great plus
Start date: ASAP
Duration: 1 year + extension possibleInterested?
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? For more information, please contact Beata Wydurska on +31 (0)20 20 44 502