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.