Our client is a fast growing generics pharmaceutical manufacturing organization in need of a GMP QA consultant to help prepare their manufacturing facility for an upcoming inspection.

Our client is expecting to be audited soon, so they need this person to get started quickly. This is a 6-12 month assignment with strong likelihood of extension.

Our client strongly prefers a local candidate who can be onsite 2-3 days / week at least.

Responsibilities

• GMP documentation generation and signing for controlled master files that stay on-site
• Facility quality management activities and ensuring that the facility is up to date and compliant
• Batch record generation
• SOP generation / writing
• Document review / signage
• Design and review in-process release testing
• Work with and qualify new vendors
• Create new quality manual and help implement new QMS system.

Requirements

• BS Degree minimum; 5-10 years of relevant industry experience
• Strong GMP Quality Assurance background
• Prior RX experience (prescription drug MFG)
• Prior experience working at a CDMO highly preferred

Last updated : 2024-05-22