Description
A global pharmaceutical contract manufacturing company is urgently looking for a GMP Compliance Manager (German speaking) to manage and prepare for various regulatory inspections.This will be an exciting opportunity to get involved in a key compliance initiative.
Location: Stuttgart area, Germany
Duration: 6 months +
Role and Responsibilities:
• Manage inspections of the manufacturing facilities (solid, sterile and packaging) by local German, EU and FDA regulatory authorities
• Lead the preparation for inspections
• Managing cross functional preparation teams from different departments for each inspection
• Ensure that all production facilities are GMP compliance prior to inspections
• Writing post inspection reports and supporting the creation of remediation plans
Requirements:
• Degree educated in Chemistry, Pharmacy, Biology or equivalent
• Fluent German language skills (spoken and written)
• Experience working with finished pharmaceutical production processes (solid, sterile and packaging)
• Experience managing GMP inspections and audits
• Good knowledge of German, EU and FDA regulatory standards
Apply now to be considered for this challenging role.