Vacancy caducado!
Duties and Responsibilities
Provide Quality oversight of supply operations and data review for accuracy, completeness, and conformance to current Good Manufacturing Practices (cGMP).
Serve as the company cGMP subject matter expert.
Monitor and audit vendors labeling, packaging, and shipping for cGMP compliance. Ensure audit responses/corrective actions are completed are completed in a timely manner.
Analyze and report quality trends to company management.
Review and approve all associated supply batch records.
Provide appropriate risk analysis to make critical decisions.
Maintain a current working knowledge of the GMP requirements, industry practices, internal policies and SOPs that impact regulatory compliance.
Interact closely with supply groups and other development team members as necessary.
Other responsibilities as assigned by the supervisor.
Vacancy caducado!