Responsible for Collection, compilation, analysis, and review of all data for APQR.
Responsible for Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow.
Responsible for Review/approval of all documentation associated with the process validation ,CPV & cleaning validation.
Responsible for processing of documents through the generation, modification, review, and approval and archival of records.
Responsible for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
Responsible for tracking, trending, and reporting of Quality Metrics for site, regional, and global
review. Trending as required by SOP, Corp. Standards, and/or regulations.
Responsible for Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.
Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations.
Responsible for Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.
Responsible for Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and/or the utilities associated with the site.