Quality activities achieved:
- Managed a QC lab for physicochemical and microbiological analysis (LCA)
- Set up specifications and stability protocols for tox and clinical batches (GSK)
- Verified documentation for batch release (GSK, LCA, DHL)
- Subject matter expert for SOP management and good documentation practices (GSK)
- Managed the QA program for a GLP facility and designed a new quality system when the facility was moved to Singapore (PMRL)
- Drafted SOPs, conceived QMS (GSK, PMRL, LCA, DHL-PL)
- Prepared inspection, executed internal/external audits, implemented CAPAs (GSK, PMRL, LCA, DHL-PL)
Transversal activities realized:
- Improved SOPs applicable to the whole industrial organization (GSK)
- Set-up specification in collaboration with production, analytical coordinators, QA and regulatory (GSK)
- Performed assessment of returned pharmaceutical products and recalls (DHL)
- Interfaced QC laboratory and external customers for price offers and reporting (LCA)