The Department: The department sees to that quality systems are applied as per GMP standards and is responsible for handling deviations, intermediate release and change control. The QA department plays an important role in providing advice on quality topics to all departments, which are part of the supply chain.
Specific tasks: In the position as Quality Assurance Consultant you are the quality expert who, in cooperation with all supply chain departments, monitors and improves the quality of our production and quality systems in a constructive manner. You are therefore the first contact person for all departments with regards to quality issues and you work together with the respectively subject matter experts of these departments (Operations, QC and RA).
In case of deviations, you assess/review the outcome of the initial investigation and the proposed corrective actions. Furthermore you assess and oversee the quality of its related documentation.
You are part of the deviation team investigation teams and monitor the quality of the Root Cause investigations. You assess potential consequences of deviations on the quality of our products. For specific deviations you also take the lead on the investigation yourself.
- You review and sign of investigation reports.
- You participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients.
- You participate in NPI (New Product Introduction), quality and capacity projects.
- You act as local quality owner, One Lab QA contact and you lead risk assessments.
- You are actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor (Operations, QC, etc). You align and agree on improvement actions with the departmental subject matter expert and you follow up on the agreed solutions.
- Outside office hours you act as QA representative on a roulation basis with other colleagues and you can be reached by the pager or business mobile phone (24/7).
- You approve change notices (procedures) in name of QA.
- Academic and HBO (higher education) in biochemistry, biology or a pharmaceutical degree, and depending on education,
- Up to 5 years relevant working experience in a GMP environment.
- You have a great sense for quality and excellent analytical abilities.
- You can make well motivated decisions on your own.
- Experience in data analytics, vaccines and New product introduction is a pre.
- You have an excellent proficiency in English both in word and in writing.
- You have strong oral and written communication skills
Start: on short notice / in consultation
Period: 6+ month's
Location: several locations in the Netherlands
Interested? Please respond with your resume, hourly rate and availability.