We are currently recruiting for a top pharmaceutical organization with an exciting opportunity.
Job Overview
* Leads investigations for fill/finish and inspection deviations, applying process knowledge and compliance standards.
* Manages deviation investigations, including establishing investigation teams and leading root cause analysis.
Key Responsibilities
* Drives improvements to the investigation process and presents findings to regulatory inspectors.
* Communicates investigation progress to leadership and coordinates cross-functional teams through complex investigations.
Requirements
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in biotech/pharma manufacturing.
* Detailed technical understanding of fill/finish operations, experience with problem-solving, root cause analysis, and quality systems.
Desirable Skills
* Technical writing and project management skills.
* Able to apply critical thinking and inductive reasoning in the investigation process.