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  • Location

    Netherlands

  • Job title:

    Associate GMP Specialist

  • Sector:

  • Job ref:

    44558

  • Startdate:

    2020-07-15

The company

Our client is an important player in the pharmaceutical industry

Role 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 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 GMP documentation up-to-date.
- Support in improvements on production processes and systems
- Support in improvements regarding relevant EHSS standards applicable
- Writing change controls for the GMP/ EHS systems
- Support lead deviation investigation in documenting product impact analysis and root cause investigation
- Coordinator internal batch release
- Leading process excellence activities to continuously improve the work as well as personal skills

Requirements

- 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
- Experience with cGMP and EHSS standards is required
- Experience with Trackwise QEM, Docspace and CURVE is preferred
- General knowledge in cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP)

Other information

If you are interested in this role, please contact me at t.voichenko@sire-search.com or at +31 20 658 98 00.

Contact