Description
A European-wide generic pharmaceuticals company is looking for an experienced Project Manager to lead the FDA certification of one of its manufacturing sites.Location: Madrid, Spain
Duration: 1-2 years
Role and Responsibilities:
Lead the FDA certification of a sterile filling site (currently only EU certified) and ensure that milestones are met within the required timescales
Liaise between and manage the different departments involved in this project (Quality, Validation, Production )
Carry out a gap assessment on the site
Update CAPA plans
Update the site's quality systems and quality manual to meet FDA requirements
Carry out internal audits and a pre-audit inspection (PAI)
Requirements:
Degree educated in scientific or engineering discipline or equivalent
Background in pharmaceutical QA, quality management, validation or similar
Knowledge of and experience working with sterile filling processes
Good knowledge of FDA regulations
Experience leading compliance projects and audits
This will be an exciting opportunity to deliver an important strategic project.