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Product Quality Integrator

Vacaturenummer: A2100103
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a Product Quality Integrator.

Keywords

  • MSc.
  • Quality (Assurance)
  • cGMP
  • Covid-19


Profile
The Product Quality Management (PQM) team at Janssen Vaccines is looking an all-round quality professional to support the team in the Covid-19 vaccine project. The position is linked to the Janssen Vaccines & Prevention organisation, which is based in Leiden, the Netherlands You will ensure that product quality aspects of the Covid-19 vaccines, including the original variant and new variants, are tracked and consistently met. Also, you ensure that information and data on the Covid-19 vaccine project are structured for easy access and interpretation. In (sub)projects for the vaccine, you will represent PQM on the project team. Also, you will be working hands-on at operational activities such as complaints, deviations, change controls, and regulatory reviews. In all activities, you bring creative solutions to define quality solutions with flexibility for business needs.

Who we're looking for
A Master’s or advanced degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or Life Sciences and at least 5 years’ experience in the pharmaceutical and/or biotechnology industry is required. A significant part of this experience should be in the area of Quality (Assurance).
You have proven knowledge in cGMP standards, policies and procedures. You have demonstrated knowledge of and/or experience in quality systems and processes, e.g., change control, deviation handling, CAPA, risk management, complaints handling, (regulatory) inspections, and manufacturing control strategies. Knowledge of and experience in the following areas is preferred: biotechnology, vaccines, API manufacturing, sterile pharmaceutical manufacturing, process development, technology transfer, process validation, developing quality modules of regulatory filings
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary.


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 organisation, 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:A2100103
Contract:Temporary contract with CLS Services
Education:WO/MSc.
Employment terms:Days of leave: 25 + 11
See here our other employment terms for this vacancy
Publication date:14-5-2021
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.