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Associate GMP Specialist

Would you like to be directly involved in the fight against the global
"Corona virus" (COVID-19) pandemic? Then keep reading!

Job description

You will work within the Vaccine Launch Facility (VLF). A state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where we produce vaccines against infectious diseases, such as HIV RSV. As a response to the global COVID-19 pandamic the VLF has been appointed as one of the production sites for Janssen's lead vaccine candidate for COVID-19.

As associate GMP specialist, you will support the operations teams in general cGMP and EHS related tasks (changes, quality issues, training, GMP and EHS documentation and reports). Thus, the GMP associate also supports a safe, healthy and sustainable work environment.

In different team settings, you will work on maintenance and improvement of the general VLF GMP procedures and GMP systems to ensure successful production runs can be produced. Furthermore, you will (pro) actively assist in safety related issues and improvements.

As GMP associate, you work closely with your Center of Expertise colleague's and the VLF staff engineers and with the all the other teams of the VLF. As well as GMP_Training, Document control department, QA department, and Compliance department.

Responsibilities

  • Support in keeping general VLF GMP documentation up-to-date.

  • Support in improvements on production processes and systems within the VLF.

  • Support in improvements regarding relevant EHSS standards applicable to the VLF (including support in on-going EHSS investigations.

  • Writing change controls for the GMP/ EHS systems and VLF improvements, and responsible for follow up and timely documentation and completion.

  • Support lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion.

  • Training coordinator and responsible for the training-syllabi within the VLF.

  • Coordinator of documentation periodic review within the VLF.

  • Coordinator internal batch release (WVS, IVP, DS)

  • Manage customer feedback

  • Assist in legal documentation

Profile

  • BSc or MSc in the fields Biochemistry, Life Science or similar (Phd or MBA is considered overqualified for this position

  • General knowledge in cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP).

  • Excellent communication skills, and a team player attitude

  • Good project management skills

  • Experience with Trackwise QEM, Docspace and CURVE is preferred

  • Fluency in Dutch + English

Terms of employment

  • Employment: temporary contract with prospect of a permanent contract

  • Salary indication: from € 3500 to € 4300 gross a month

  • Working hours: 40 hours per week (part-time can be discussed)

  • Location: Leiden region

Vacancy number; 15493