(Sr) QA Associate farma (GMP)
In the position as QA Associate 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.
o 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.
o 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.
o You review and sign of investigation reports. Moreover you are responsible for the closure of deviation and CAPA records in Trackwise.
o You participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients.
o You participate in NPI (New Product Introduction), quality and capacity projects.
o You act as local quality owner, One Lab QA contact and you lead risk assessments.
o 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.
o 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).
o 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, 5 to 7 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
- Experience in methods such as Process Excellence, Co Think and Kepner-Tregoe is recommended.
Janssen Biologics, part of Johnson and Johnson is a leading multinational in the field of biopharmaceutrical production. Recruitment for this position is mediated by LabResource as their top-tier supplier.
The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling deviations, bulk and 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. To fill in the opening due to a leaving colleague, we are looking for an enthusiastic and driven new colleague who can take up this challenging role as QA Associate. If you would like to know the company better, then this a great opportunity!
conditions: budgetary approval for 6 months, extension is hoped for / anticipated but no guaranties can be given at this moment
contract: via LabResource
hours: full-time, 32 hours discussable
holidays: 25+12 based
Salary: €3000-€4000 bruto/maand