• 07 juli 2022
  • vacaturenummer: 544464

Do you have the ambition to work in a large company as a GMP Specialiast? Do you have a completed bachelor or master's degree in Microbiology, Biochemistry, Pharmacy, Biotechnology, or Engineering? And are you looking for a job in the short term? Then read on quickly!

Janssen Biologics B.V. has a leading position in the world of biotechnology. They develop, produce and sell medicine that are used worldwide in the fight against cardiovascular-, vascular- and infectious diseases and autoimmune diseases such as Crohn's disease and Rheumatism.

Competitive salary depended on your experience

Instantly employed by Janssen Biologics B.V.

A workplace at an international organization

Opportunities to develop yourself

A working week of 40 hours

A pleasant working environment

Do you recognize yourself in the listed aspects below?
To apply for this job it is important to have a European passport or a valid work permit for working in the Netherlands.

  • You have a completed bachelor or master's degree in Microbiology, Biochemistry, Pharmacy, Biotechnology, or Engineering
  • Min 2-5 years relevant working experience in a biotechnology or bio pharmaceutical environment (Technical background (TU) is also valid)
  • Excellent interpersonal and communication skills
  • You have an high degree of accuracy, initiative, and independence
  • You are fluent in the English language, both verbally and in writing

As a GMP specialist – Deviations Lead - you will be responsible for leading the deviation investigations of any deviation that occurs in the manufacturing facility. You will be responsible for the closed loop approach to investigations, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions. You are responsible that progress is documented in a compliant way.  Additionally, you will also work on maintenance and improvement of general GMP processes, as needed. Examples are support in emergency Change Controls, Training, updating general GMP procedures, support in inspections etc.

  • Lead deviation investigation in documenting product impact analysis and root cause investigation, including CAPA records
  • Responsible for follow up, and ensuring compliant documentation and timely completion
  • Ensuring that relevant corrections and/or improvements on production processes and systems are made within the BCPO
  • Monitor progress and KPI's for this process

Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Bio-therapeutics and Vaccines. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At Janssen Biologics, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark!

- After receiving your application, you will hear from us as soon as possible.
- If we find you suitable based on your CV and motivation, we will call you for a selection interview.
- We will ask you for two references.
- If the outcome of the selection interview is positive, we will introduce you to Janssen Biologics.

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