CLS Services

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QA Associate

Leiden
Gepubliceerd: ongeveer 1 maand geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Biologics B.V.</STRONG>, we are searching for a QA Associate.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Department
The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics 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!

Job description
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 (Operations, One Lab, MAM, VLF and DPDS). This position will be placed within the New Product Introduction (NPI) branch.

Responsibilities:

  • 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;
  • Review and sign of investigation related reports. Moreover you are responsible for the closure of the Quality Investigations and CPA records in Trackwise;
  • Participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients;
  • 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;
  • Approve change notices (procedures) in name of QA and handle change controls in relation to CPA actions;
  • Participate in NPI, quality and capacity projects.


Who we're looking for
We are looking for MSc or BSc candidates with a background 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, excellent analytical abilities and you can make well motivated decisions on your own. Experience in data analytics, vaccines and new product introduction is a plus as well as experience in methods such as Process Excellence, Co Think or Kepner-Tregoe.
Are you the enthousiastic and driven candidate with excellent English communication skills we are looking for?

Additional vacancy information
Reference: A1900096
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Project for six months due to maternity leave. Currently no possibilities to extend, but other opportunities may arise. Full time preferred, 32 hours discussable.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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