5 JAN '24: For a Leiden-based organisation comprising a state-of-the-art facility and expert knowledge on the development, production, and commercialisation of Cell and Gene Therapies, we are currently looking for a Senior QA Specialist. They help academic and industrial developers enter the clinical stage by combining the required expertise in a brand-new development & GMP manufacturing facility.
Leiden - Netherlands
40 uur per week
Over jouw rol
Zo maak jij het verschil
Wat nodig is
Wat jij mee brengt
- MSc in Biotechnology, chemistry, biopharmaceutics, or equivalent;
- Proficient in cGMP, GDP, and regulations promulgated by the EMA or equivalent regulatory agencies;
- Eight years of recent experience in (bio)pharmaceutical environment with at least five years of recent experience in Quality Assurance;
- Experience within a sterile manufacturing environment, preferably ATMPs (biologicals, vaccines, injectables, parenteral);
- Good communication skills in English (verbally and written);
- Willingness to travel: Occasional trips are needed for audit program support.
Wat wij bieden
- A 13th-month payment and an 8% holiday allowance;
- The unique opportunity to co-define the organisation and contribute to the organisation's establishment;
- Your expertise is critical for their successful further scaling, meaning you will enjoy a lot of responsibility and impact regarding key decisions.
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