Description
QA/Validation Specialist - German SpeakingOur global pharmaceutical client currently has a contract requirement for an experienced QA/ Validation Specialist for a contract role based in Germany.
The client has been undergoing a large overhaul of their QA systems following on from an internal audit and is looking for additional support from a candidate experienced with QA/Validation documentation.
Activity list:
• Review already existing validation documents for compliance with GMP/FDA regulations as well as adherence to HQ SOPs.
• Review validation (master) plans to identify gaps and implement solutions.
• Support the project overall with QA and validation expertise.
• Help to create an overview of the validation status of the onsite equipment for HQ.
To be successful for this role you will have the following skills/experience:-
• Must be German and English speaking/reading/writing - the documents are written in the German language.
• Experience of QA/Validation documentation writing or review essential.
• Knowledge of regulatory requirements (GMP, FDA).
• Strong experience in a pharmaceutical environment - experience with medical devices a distinct bonus.
• QA background is advantageous.
• Good communication and organisational skills.