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Jr. QA / Documentalist

Vacaturenummer: A2000186
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a Jr. QA / Documentalist .

Keywords

  • QA.
  • GxP.
  • SOP documentation.
  • Equipment/Software validation.


Profile
Due to the increased demand because of the COVID vaccine program we are looking for a Jr. QA/Documentalist within the Clinical Immunology department. Clinical Immunology is responsible for coordinating and performing clinical sample analysis in support of the clinical vaccine trials. In your role as Jr. QA, you are responsible to ensure correct approval of all GCLP relevant SOP’s and to perform quality review and approval of all documents created in the document management system. Additionally, you perform reviews for alignment with other GCLP procedures, layout, template, revision history and other quality related details.

Other responsibilities:
  • Coordinate the deviations for the GCLP facility: ensure the timely reporting and closure, assist GCLP personnel in writing deviations, track status and alert when due dates are approaching, review all deviations and give feedback on content;
  • Assist in the follow up of audit findings;
  • Review completeness of training files of GCLP personnel;
  • Assign training curricula to GCLP personnel;
  • Write/review equipment validation protocols;
  • Write/review software test protocols;
  • Review validation documents.


Who we're looking for
The ideal candidate has a BSc. background and at least 2 years relevant experience with quality systems (GxP). You have expereince with equipment and / or software validation. You are able to write, edit and review quality related documents in English. Experience with performing immunological assays is a pre.

Company profile
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.



Additional vacancy information
Reference:A2000186
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:8 month contract, 32 hours/week
Salary: >2600
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Publication date:1-2-2021
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.