Description
QA Documentation Specialist - ProductionThe QA Documentation Specialist will be supporting our global pharmaceutical client in the transformation of a chemical site into a biomanfacturing facility. This role will be supporting the Documentation Manager (Production) through the introduction of new governance and system upgrade.
Location: Paris region
Duration: 6-9 months
Key activities include, but are not limited, to;
• Review of production documentation for compliance with GMP and FDA requirements.
• Executing activities in support of aligning site and corporate compliance standards - gap assessment execution, closure of gaps and corrective actions required in support of same.
• Supporting the transition to new governance requirements.
• Supporting the documentation manager through the change to an upgraded documentation system.
• Controlling and archiving of GMP documentation.
Candidate Requirements: •
• Excellent QA experience within a global company setting.
• Experience gained within a biologics environment.
• 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.
• Familiarity with GMP and FDA requirements essential.