QA Documentation Specialist Production

Description

QA Documentation Specialist - Production
The 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.