The key point of contact for the QMS including Deviations, CAPAs, Effectiveness Checks, and Change Controls.
Participate in Change Control Review Board by identifying gaps, risks, procedural requirements, and regulatory requirements and ensure actions are initiated to ensure compliance and mitigate risks.
Support GMP validation projects of low to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources
Oversee qualification activities in cGMP validation best practices
Primary responsibility is to lead CSV strategy and execution for GMP computerized systems supporting manufacturing, laboratory, facilities, automation, quality, and supporting infrastructure.
Serve as the CSV subject matter expert for assigned systems, capital projects, client programs, change controls, investigations, and remediation activities.
Responsible for all aspects of batch disposition for designated client programs including real-time tracking of batch and documentation, cross-functional development of release timelines, communication of timelines and progress both internally and externally
Responsible for ensuring all documentation required for batch disposition is in the appropriate...
