What will your job be
As Specialist Viral Assays you support the required analytical activity and, additionally, will actively handle quality and compliance related topics. this includes:
- Medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls.
- contributions to maintaining cGMP compliance and support the LEAN status of the team
- Act as SME during cGMP inspections and is NPI contact person during tech. transfer
- Responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe
- Servomg as an expert on AVA/Mycoplasma technologies and will be requested to represent the team during internal/external meetingsresponsible for creating URS’s in collaboration with automation specialist and provides lab input for the new equipment or technologies to NPI Lead
You will also be responsible for deviation management within the COVID-19 Vaccine Test Team. This includes:
- 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
- Supporting and advising other lead investigators from external and internal QC departments.
- Responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues.
- Monitor timely closure of medium/high-level investigations and associated CRA’s
What are we looking for
For the position as Specialist Viral Assays we are looking for a candidate with at least 2-4 years of pharmaceutical experience, further more you have:
- A relevant BSc or MSc degree towards biosciences, pharmacy, (analytical) chemistry etc
- Good technical writing skill in English
- Good knowledge of statistical data analyse
- Effective skills to transfer information in a training environment
What do we offer
- Long term position, which starts with a 12 months contract at CheckMark
- Salary indication from €3078 gross per month based on a full-time position
- Full-time position,
Where will you work
Our client in the region of Leiden is a pharmaceutical company specialised in the production of vaccines. The Vaccine Test Team is responsible for the execution of all analytical test methods using, amongst others, various AVA/Mycoplasma and biophysical techniques.