Quality Specialists - Austria

Austria  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Quality Specialists - CPAT - Comprehensive Product Assessment and Trending

Global 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.
Start date
n.a
From
Quanta Consultancy Services
Published at
07.11.2012
Contact person:
Lee Mitchell
Project ID:
444576
Contract type
Freelance
To apply to this project you must log in.
Register