Short biography
Chartered Quality Professional – (Independent Consultant)
IRCA ; MCQI ; CQP (UK) ; Exemplar Global LA & SE (USA/AUS).
Comprehensive review of SOPs, relating to the QMS, including Design/ Manufacturing Transfer, Validations; CAPA; Root Cause Analysis and Investigations to ensure compliance to cGMP. Training Internal and External Quality System Auditors to ensure compliance with revised standards, not limited to ISO 9001:2015; ISO 14001:2015; ISO 13485:2016, ISO 17025:2005; EN ISO 11135-1:2007; EN ISO 11137-1:2006; CMDR, and MDD, TGA, PAL. Supporting Client Global Supplier Initiative for Supplier and Supply Chain process. Quality Agreements. Reviewing and updating DFMEA’s & PFMEA’s to support actions taken identified in Audits, Customer Complaints, Process and Design Changes; Batch Records etc.