We are looking for an expert in the field of QA, pharmaceutical quality and safety. Are you looking for a challenge in the direction of validation and qualification in a GMP environment? Then apply for the position of quality engineer.
Job Description
If you want to work for a large international company that focusses its efforts towards treating diseases, then keep reading. For a new business unit we are looking for someone to contribute to setting up this supply facility. From a quality perspective you will make sure that this production site is GMP compliant and that the correct biosafety level is achieved (BSL-2). You will be involved from the start with design of the facility, until qualification and validation of the equipment and processes, providing ideas from your perspective as quality and compliance expert. You need to be able to keep overview and work on large projects. Both zooming out to see the whole picture, as well as zooming and noticing every little detail is crucial in this position. Apply now, and take on this exciting challenge!
Responsibilities
- Ensure that all qualifications and validations meet regulatory requirements;
- Managing quality guidelines of the facility, equipment and process;
- Work on the new facility, making sure all operations are fit for use and compliant with GMP;
- Leadership, coaching staff in quality and safety requirements;
- Risk assessment and acting accordingly;
- Partake in meetings, providing input for continuous improvement and quality;
- Organize your work and carry responsibility for you decisions;
Requirements
- Bachelor degree or higher in bioprocess engineering, biochemistry, pharmaceutical sciences or equivalent;
- A minimum of 5 years of work experience in a GMP environment is required;
- Proven experience in a quality oriented position in the biotech of pharmaceutical industry, preferably in qualification and validation work;
- In depth expertise on global regulatory guidelines such as cGMP, ICH, FDA etc.;
- Knowledge of QA processes, change control, deviation management, CAPA's and documentation systems;
- Excellent verbal and written skills in English;
- A pro-active selfstarter that actively gives input on improvement projects;
- Automation experience and affinity is a pré;
- A risk based mindset with attention for detail;
Benefits
- Contract: Start on a year contract trough Oxford Global Resources, possibility for extension;
- Salary: €3900 - €6500, based on experience;
- Working hours: 32-40 hours per week;
- Region: Leiden;
- Vacancy number: 20624;
