Conduction of gap analysis audits and advice on remedial actions
Project management of audit preparations in line with quality requirements (experienced in handling audits by, among others, the US FDA)
Assistance with formulating responses for audit findings
Auditing of 3rd party manufacturers, suppliers of raw materials and components on behalf of clients
Conduction of root cause analysis investigations, quality risk assessments and plans for corrective actions and preventative actions (CAPA)
Training of personnel on QMS and Good Manufacturing Practice (GMP)
Execution of Validation Studies: Process Validation and Analytical Test Methods
Compilation of pertinent regulatory documentation such as Standard Operating Procedures (SOPs), Site Master Files (SMF), Quality Manuals, Validation Master Plans (VMP)