Subject Matter Expert - QC GMP

We are looking for an experienced technician or analyst for the QC-department of an international biotech firm in Amsterdam. You act as an SME regarding GMP-guidelines and analytical techniques (HPLC focus) in this role. Apply today if you are looking for a next step and have this experience!

Job

Job description

This role is in a dynamic company that does project-based work. This means that the analyses in the QC-department are often similar, but rarely the same. Therefore, we are actively recruiting a senior technician to mentor technicians and ensure GMP-compliant analysis of biopharmaceutical products. You will occasionally be on the lab yourself to troubleshoot, help with validations, and any other non-routine issues the teams might face. You spend most of your time writing SOPs, reviewing documents before it is sent to QA, performing investigations, implementing CAPAs, and of course answering questions from the team. You do not have any direct reports but you are an escalation point for the technicians with anything technical. This department does a wide range of analyses, the focus is on HPLC, Capillary Electrophoresis, and UV-spectroscopy.

Responsibilities

Act as an SME for the QC department
Ensure GMP-compliance
Write SOPs
Perform investigations, implement CAPAs
Troubleshoot with laboratory equipment when needed

Profile

HBO/BSc degree in a relevant field like biochemistry, analytical chemistry or pharmaceutical science
At least 5 years of GMP-experience
Strong experience with HPLC
Someone with a master's degree can fit well, candidates with a PhD will not be considered for this role
Fluent in English, Dutch is a plus

Benefits