GMP Documentation Specialist

Basel-Stadt  ‐ Vor Ort
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Schlagworte

Beschreibung

Our client is a world leader in the pharmaceutical business. We are currently looking for a German speaking GMP Documentation Specialist to support their team.

Important: For this role previous experience in clinical manufacturing.

Main responsibilities:

  • Compilation and review GMP compliant manufacturing documentation for clinical supplies in an electronic batch recording system in close collaboration with formulation experts and manufacturing operators.
  • You are working as documentation specialist in a pilot plant for solid dosage forms.
  • You compile the master batch records based on information provided by our formulation experts and you prepare the executed batch records for review by the formulation experts and for approval by quality assurance.
  • In the team of documentation specialist, you contribute to continuous improvement of the manufacturing documentation in a newly introduced electronic batch recording system
  • In addition, you take over other administrative tasks, eg writing of SOPs, writing of cleaning validation assessments. 

Ideal profile:

  • Completed apprenticeship or equivalent (no master or PhD levels), preferably in pharmaceutical sciences
  • Experience in the area of clinical manufacturing
  • Experience in GMP compliant manufacturing documentation and basic knowledge of manufacturing processes for solid dosage forms
  • Fluency in German and English is essential
  • A high sense of responsibility, but also creativity, the willingness to work in teams are necessary for the position.
Start
keine Angabe
Von
Stamford Consultants AG
Eingestellt
24.07.2014
Projekt-ID:
747180
Vertragsart
Freiberuflich
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