I have a Masters in chemistry. More than 16 years’ experience in the field of process control, quality and regulatory fields and QA/QC analytical systems.
- Knowledge of filing drug approval applications, supplementary applications, and experience in responding to regulatory enquiries
- Experience in writing, reviewing and approving the validation (IOPQ) documents of major utilities in the manufacturing areas, laboratory equipment and analytical methods.
- Experience in preserving GxP (GMP, GCP, GLP), (US and EU) compliance in the API, parenteral and medical device manufacturing facility
- Ensure electronic documentation software used in manufacturing and laboratory equipment meet 21 CFR part 11 requirements
- Participate in regulatory agency audits, US and EU and prepared responses to the agency audit reports
- Participate in review and approval of manufacturing and laboratory documentation
- Certified ISO-9000 Internal Quality Auditing
- Certified Quality Auditor (CQA) by ASQ