Description
The QA Documentation Specialist will be supporting our global pharmaceutical client in the transformation of a chemical site into a bio-manfacturing facility. This role will work as part of the project team to take part in the review of equipment qualification and support the introduction of new equipment.Key activities include but are not limited to:
• Review of equipment qualification documentation for existing equipment.
• Review and improvement of compliance to GMP and FDA requirement.
• 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.
• Controlling and archiving of GMP documentation
• Support with the introduction of new equipment including writing of required documentation.
Candidate Requirements:
• Excellent QA experience within a global QA team 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 for the qualification of biotech/biopharma equipment.
• Fluent French language skills, required.