I am urgently looking for a motivated Technical Expert to join a leading Biotech in Leiden to support the quality and compliance related issues, deviations, CAPA, assessments. Act as Subject Matter Expert (SME) during cGMP inspections and is New Product Introductions (NPI) contact person during the new product implementation process.
- 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.
- Monitor 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.
- coordinates activities related to NPI introductions.
- ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, adheres to cGMP and is safe. Including GAP analysis performed during the new product implementation.
- crafting URS’s in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
- data gathering for assay performance, including raw data. Analyze the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different teams (other sites, DPDS)
- Leads and drives continuous improvement processes.
- Good technical writing skill in English
- Knowledge of statistical data analyses
- Didactical skills to effectively transfer information in a training environment
- Organizational skills in order to effectively coordinate a project
- Minimum of 2 years of experience working in a GMP lab
- Minimum of 2 years of experience with biological assays
- 1st September 2021
- Full time position
- 1 year contract ending on 31 August 2022 (Extension highly likely)
- Location: Leiden
Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org