Wat ga je doen?
Intravacc (the institute for Translational Vaccine) is looking for a Specialist on quality assurance. This function is unique and versatile in it’s nature because Intravacc has the triple combination of product development, test development and a GMP production facility. There is small QA team that monitors the different facets that come with three the before mentioned segments, this is what makes this job a real challenge.
The function consists of following tasks:
- Arranging and optimizing of the (quality)processes to remain durably compliant to laws and legislation;
- Leading improvement projects concerning quality;
- Advising on the approval of the qualifications of complex equipment/machines;
- Advising of the organisation during product development and analytical development trials. You will do this by contributing in the forming of documents concerning risk analysis, specifications, batch documentation, test documentation, validation documentation and more. Whilst putting ICH guidelines in to practice and insuring GMP compliance in the final vaccin product;
- Selecting and qualifying of contractors (CMO’s and contractlaboratorys). You will be responsible for the contracts and product specific documentation;
- Working on the upkeep and optimisation of the quality management system;
- The upkeep and increasing of the quality awareness and GMP level within the organisation.
Wat wij bieden:
- A fulltime job of 36 hours per week;
- A temporary position, at least until march 2020 with the option to extend the period;
- A gross monthly salary in between €3667 and €5450 depending on your work experience;
- Travel expenses compensation;
- A varied and challenging job;
Wat wij vragen:
- Minimaal een hbo-diploma; in a relevant subject
- Knowledge of EU-GMP, FDA and ICH guidelines;
- A minimum of 10 years of experience on QA within the biopharmaceutical industry;
- Preferably knowledge or affinity with (the validation of) data management systems;
- Preferably experience with the (analytical) development of (bio)pharmaceutical products;
- Command of the English language is a must, command of the Dutch language is a plus;
Ben jij de perfecte kandidaat voor deze vacature en voldoe je aan de eisen? Klik dan op de knop 'Solliciteer direct!' en we nemen zo snel mogelijk contact met je op!
- Werkuren per week
- 36 - 36
- Fulltime (ervaren)
Tussen €3.667 en €5.450 per maand
- Verantwoordelijk voor
- Quality related tasks in the development, testing and production of vaccines.