QA GMP Expert

Beschreibung

QA GMP Expert

Our biopharmaceutical client is looking for a GMP Expert (German speaking), to provide support in preparation for an upcoming PAI audit. They are currently undergoing a transformation programme to initiate the start-up of their first commercial production.

Role and Responsibilities:
• Support with preparation for PAI audit.
• “Quality on the floor” support
• Identification and remediation of any quality issues or weaknesses.
• Provision of training for the QA team.

Requirements:
• Previous experience working in a biopharmaceutical/ biotech environment.
• Outstanding knowledge of QA including GMP and FDA requirement.
• Experience of supporting both manufacturing and ideally also QC departments.
• Experience of writing documentation to QA standards - for example validation/URS/SOP documentation.
• Prior experience of preparation for PAI audit beneficial.
• Hands on individual who works well within a team required.
• Fluent German language skills essential.