Description
QA Specialist (Stability Studies)A global biopharmaceutical company is looking for a QA Specialist (English and German speaking) to support their stability team in reviewing stability protocols and reporting for product registration in new markets.
Location: Central Switzerland
Duration: 2 months
Role and Responsibilities:
• Review current protocols for stability studies - scope, frequency and parameters of testing.
• Update stability protocols to include up to date information.
• Use existing templates and information to create new protocols for the new market registrations.
Requirements:
• Pharmaceutical experience essential
• Experience of writing documentation to QA standards - for example validation/URS/SOP documentation.
• Experience of OOS or stability studies and reports advantageous, but not required.
• Strong knowledge of GMP regulations
• Strong ability to learn quickly and adapt knowledge to a new area.
• Analytical and technical mind set - able to apply principles to new areas.
• Fluent English written abilities essential- understanding of German written documentation required.