Description
QA Documentation SpecialistOur global pharmaceutical client is looking for a QA Documentation Specialist to support them in the introduction of a new product. The sterile Fill/Finish environment is new to the client so they are looking for a consultant able to bring extensive knowledge and understanding as well as provide coaching for inhouse staff.
Key activities include but are not limited to:
• Review of Engineering plans.
• Qualification documentation writing, review and approval.
• Review of URS and SOP
• Implementation of procedures in accordance with GMP/FDA requirements
• Coaching of permanent staff members
Candidate Requirements:
• Excellent QA experience within a global QA team setting.
• Strong pharmaceutical experience within the fill/finish area.
• Knowledge of regulations and documentation surrounding isolators very beneficial
• Experience of writing documentation for a lyophiliser.
• Experience of documentation for a new product introduction desirable.
• Strong communication skills. The job holder will be required to work closely with both internal and external stakeholders and should be capable of working both independently and within a team setting.
• English language skills essential, German language skills nice to have.