Minimum of Bachelor's Degree in Science or Engineering, or related. Role will require focused expertise in sterile operations, quality and laboratory controls to improve SOPs associated with CAPAs and to initiate Change Controls, as applicable.
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Strong writing aptitude and ability to review technical documents
• Review proposed changes that might affect validated or controlled status of manufacturing practices
• Draft SOPs in response to CAPAs and initiate the associated change controls
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.