Injectable Pharmaceutical Manufacturer
Prepared Quality by Design documentation for legacy products: Critical Quality Attributes, Critical Quality Attributes vs Unit Operations and Risk Assessment using pFMEA.
Novelty Pharmaceutical Manufacturer
Provided project management for product defect CAPA and re-writing of CAPA procedures and policies, aligning documents with ICH Q9 and Q10. Developed and delivered training on new CAPA procedures. Provided Quality approval on facility, Utility and Equipment Qualifications and Validations.
Improve first pass acceptance rate for confidential in vitro diagnostics manufacturer.
Fine Chemical Manufacturer
Implement EU Annex 15 requirements for products, assessing requirements, making recommendations for meeting them and finding resources to accomplish objectives. Management of toxicology project, resulting in reports of Acceptable/Permitted Daily Exposures for client's chemicals.