Description
Quality Specialists - CPAT - Comprehensive Product Assessment and TrendingGlobal pharma/biopharmaceutical organisation is currently looking to hire a team of QA Specialists to undertake a Comprehensive Product Assessment and Trending project to review numerous products from the QA perspective.
The project is made up of four sections; strong experience in at least one of the areas is required:
Regulatory Dossiers
-Review regulatory compliance to US / GMP - standards.
-Compile a report and highlight changes made and any non-compliance issues.
Analytical Methods / Validation
-Cross reference the analytical methods / validation processes that are used.
-Review the findings that have been made and logged
-Stability results of the different products
Key Quality Indicators
-Analysis of Deviations, Re-Calls, Market complaints, OOS.
-Report on the processes that are used onsite to log, action track and manage these.
Process Validation
-Review the processes - alignment to global SOPs
-Review against - US / ICH / GMP guidelines standards
Additional Requirements:
-Experience in Pharmaceuticals, ideally experience of sterile manufacturing
-Analytical Data / work
-Experience of working with GMP / ICH / US pharma standards
-Knowledge of MS-Excel / Word
-German: oral and written essential as well as fluent English
This is an exciting opening to work in dynamic team in a contract opportunity offering competitive rates of pay. Please apply now at or on for more information.