Associate GMP Specialist

As Associate GMP Specialist you will be responsible for the well-structured approach and progress of GMP Change Controls. Do you have GMP experience and does this sound like a challenge for you? Then keep on reading and apply now!

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Wat ga je doen

Within the role of Associate GMP Specialist you will be the first line support of the Change/Project lead, coordinating and facilitating Change meetings and ensuring that progress is documented in a compliant way. Responsibilities include:

  • Writing change controls for the GMP/EHS systems, improvements and responsible for follow up and timely documentation and completion
  • Keeping general GMP documentation up-to-date and support in improvements on production processes and systems within the facility
  • 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 facility
  • Support internal batch release and coordination of documentation periodic review within the facility
  • 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

Wat vragen wij

For the position Associate GMP Specialist we are looking for a candidate with a Bachelors degree in a relevent field like biotechnology or biochemistry with a high degree of accuracy, initiative and independance. Furthermore you have:

  • A minimum of 2 years relevant work experience in a biotechnology or biopharmaceutical indsutry environment
  • Working knowledge with cGMP standards is required
  • Experience in Quality Systems, specifically Change Control
  • Good communication in Dutch and English, both verbally and in writing
  • Analytical ability and dealing with complexity
  • Preferrably experience with Trackwise QEM, Docspace or similar automated systems
  • As a person you are flexible, change priorities, stress-resistant and innovative. You keep continiously innovating

Wat hebben we te bieden

  • Secondment via Checkmark Labrecruitment for one year
  • Salary indication up to €4200,- gross per month based on fulltime
  • Fulltime position (40 hours/week)

Waar ga je aan de slag

A global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Wil je meer weten?

Sebastiaan Loriaux
088 00 211 26
Jurjen Wilschut
088 00 211 22
Vacaturenummer: 7047

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