2434 Associate GMP Specialist VLF

Locatie: Leiden, Zuid-Holland, Nederland
Salaris: competitive
Sectoren: Quality Assurance
Soort functie: Freelance
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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?


The Vaccines Launch Facility:
The Vaccine Launch Facility (VLF) is 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. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes.

Department:
The Centre of Expertise (CoE) plays a central role within the VLF, divided in three expertise: 1) GMP specialism, 2) Single use technology and 3) Manufacturing systems specialism. The CoE is responsible for batch continuation by troubleshoot & support in production, robust and availability of process equipment, and control and change management of GMP processes. The CoE is key in clear translation of strategic and tactic projects to a workable process and environment for the shop floor. We always work against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing.

The CoE is part of the Operations Department which holds around 60 people and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (USP, DSP and Operations Support) and 1 Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skills on our production processes. The Centre of Expertise (COE) is a team of around 15 people.

Job Description:
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 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.

As GMP associate, you will be responsible for:
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)
Working precisely, detecting and solving acute problems and communicate possible abnormalities.
Leading process excellence activities to continuously improve the work as well as personal skills.
Note: In general, the associate role will merely have ownership on less complex GMP roles and supports the GMP specialists in complex issues or priority projects.

Qualifications:
Bachelor degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
Associate manufacturing specialist 2-4 years' experience in a biotechnology or biopharmaceutical industry environment.
1 -2 years for WO graduate
Experience with cGMP and EHSS standards is required.
Demonstrated GMP and EHSS awareness.
Experience with Trackwise QEM, Docspace and CURVE is preferred
General knowledge in cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP).

Competences:
Enthusiastic Team player, flexible, "Can do" attitude, critical and proactive.
Good communication in Dutch and English, both verbally and in writing.
High degree of accuracy, initiative, and independence.
Innovative: Continuous innovation of the work processes and working environment.
Analytical ability and dealing with complexity
Flexible, can deal with changing priorities and stress-resistant.

Are you interested please send an updated CV to g.tuinier(at)realstaffing.com or give me a call 020 5221588

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