Are you an experienced microbiology technician and are you looking for a more hands-off challenge within a pharmaceutical company in Leiden? We are looking for a QC specialist that will work on deviations, SOPs and non-conformances.
Our client is a large international pharmaceutical company that aims to combat infectious diseases.
The Microbiology test team is responsible for execution of test methods using various microbiological assays (e.g., Bioburden, Endotoxin, Sterility and Speciation testing), samples ranging from early clinical up to commercial process control, release, and stability.
In this role you will actively handle the compliance issues at the lab independently or with help of the lab technicians. You will work to maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Expert (SME) during cGMP inspections and are SPOC (Single point of contact) for the lab during new product implementations, investigations and qualifications.
- Responsible for deviation management, acting as lead investigator for non-conformances and a coordinator for CAPA's
- Create, review and update lab documentation and NPI supporting documents.
- Provide technical support to the lab, input in the services group and cooperate with key stakeholders.
- Act as a Subject Matter Expert during audits and inspections.
- Lead and drive continuous improvement projects.
- Bachelor education in a relevant field e.g. microbiology immunology, biochemistry, Life sciences, Virology;
- 3-5 years' experience with microbiology techniques; Bioburden, Endotoxin, Sterility and Speciation testing.
- Good knowledge on GMP is a plus
- A can-do mentality;
- Result-driven and hardworking;
- English is a Must, Dutch is considered a plus;
- Valid Dutch work permit is a must;
- Contract: 1 year via Oxford, realistic long- term perspective
- Salary: €3000- €3800 gross monthly based on a full-time position
- Holidays: 25
- Working hours: full-time, 32 hours discussable Region: Leiden
- Vacancy number: 20886