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QA Specialist

Vacaturenummer: A2100053
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a QA Specialist.

Keywords

  • Quality Accurance
  • GMP
  • Internal auditor
  • Trackwise
  • Rist Management


Profile
As QA specialist you will work in a multidisciplinary and dynamic team to support and drive quality. You play a key role in internal audits as lead auditor or co-auditor.
Other responsibilities:
  • Maintains the Site Master File;
  • Assesses the site risks and maintains and improves the Site Risk Register;
  • Supports and executes quality investigations (CAPA management) and change controls in a vaccine GMP environment;
  • Represents the Quality department when needed.


Who we're looking for
For this role we are looking for an experienced candidate (>5 years) with experience in quality assurance/quality control in a pharmaceutical GMP setting, by preference vaccines. You are able to work and handle quality data /dashboarding (e.g Tableau knowledge would be an asset). You have knowledge of TrackWise system to manage quality issues and change controls and knowledge of Risk management, RCA, CAPA management and Change Control Process. Additionally, you have experience with writing and maintaining a SMF and Risk Register.
As a person, you are pro-active, agile, and you enjoy working in a team. Good organizational and communication skills, creativity, problem-solving capabilities and a can-do mentality are key for this position. Good communication skills in Dutch are an advantage.


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.



Department
The Quality Assurance department at Janssen Vaccines & Prevention (V&P) in Leiden is a fast-developing department. Janssen V&P is currently working on a full Vaccine pipeline, including a COVID-19 vaccine developed at the site in Leiden and by external collaborations. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen V&P. The group is forward looking, working on improving processes, being customer focused and supports the need for speed. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

Additional vacancy information
Reference:A2100053
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:Project for 3 months with possible extension to 6 months.
Salary: >4200
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Publication date:10-3-2021
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.