Review executed batch production records for completeness, accuracy, and compliance with cGMP requirements.
Verify that all critical process steps, calculations, and documentation entries are properly completed.
Identify and resolve documentation discrepancies in collaboration with Manufacturing and QC teams.
Ensure batch documentation meets internal SOPs, regulatory requirements, and data integrity standards.
Initiate, review, and support change control documentation in accordance with the company Quality Management System (QMS).
Assess the potential impact of proposed changes on product quality, manufacturing processes, and regulatory compliance.
Coordinate cross-functional review and approval of change control records.
Review incoming raw material documentation including Certificates of Analysis (CoA), supplier documentation, and QC test results.
Support the release of raw materials, intermediates, and finished materials in accordance with GMP procedures.
Ensure traceability and documentation integrity within the material management system.
Review qualification protocols and reports (e.g., equipment qualification, facility qualification).
Ensure qualification and validation documentation meets regulatory and internal quality standards.
Support closure of qualification and validation activities.
Provide QA oversight and support to manufacturing operations to ensure compliance with cGMP requirements.
Assist with investigation and documentation of deviations and nonconformances.
Support implementation and follow-up of corrective and preventive actions (CAPA).
Participate in internal audits, quality system reviews, and regulatory inspection readiness activities.
Ensure quality documentation is accurate, complete, and compliant with company SOPs and regulatory guidelines.
Maintain QA records in accordance with data integrity principles and documentation standards.
Support continuous improvement initiatives within the Quality Management System.
