Review of paper and electronic batch records on completeness, clarity and GMP compliance;
Review of raw material related documentation and release of raw materials;
Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPAs);
Provide advice to requesting departments regarding GMP aspects;
Review and approve QA controlled documentation (SOPs, batch records, working instructions);
Assessing change requests on consistency, relevance, GMP compliance and clarity;
Review and preparation of batch release documentation;
Support in continuous improvement activities.