QA Specialist - Senior

Location: Leiden, South Holland, Netherlands
Salary: competitive
Sectors: Life Sciences
Job Type: Contract

Title: QA Specialist - Senior

The Department:
The department Quality Assurance sees to that quality systems are applied as per GMP standards within JanssenBiologics and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) 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. 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!

Specific tasks:
In the position as QA Specialist, 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, One Lab, MAM, VLF and DPDS). The QA department has a commercial and NPD/NPI branch. This position will be placed within the NPI branch.

In case of non-conformances, you assess/review the outcome of the initial investigation and the proposed corrections. Furthermore you assess and oversee the quality of its related documentation. You are part of the investigation teams and monitor the quality of the Root Cause investigations. You assess potential consequences of non-conformances on the quality of our products. You review and sign of investigation related reports.

Moreover you are responsible for the closure of the Quality Investigations and CPA records in Trackwise. You participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients. You participate in risk assessments as applicable. You are actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor (Operations, One Lab, 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 rotation 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 and handle change controls in relation to CPA actions. You participate in NPI (New Product Introduction), quality and capacity projects.

Job requirements:
- 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 plus.
You have an excellent proficiency in English both in word and in writing. Dutch is a Plus.
You have strong oral and written communication skills
Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

For more information, and to apply, send send an email to: j.vanbaalen(@) with your most recent CV and cover letter.