Quality Systems consultant for biologics, small molecule and combination products

Support Biopharmaceutical companies to establish Quality Systems and GMP manufacturing in US and Canada

A senior Quality Assurance professional with over 20 years of diversified experience in the biopharmaceutical and pharmaceutical industries

Led the Quality Assurance department for successful start of Phase 2B clinical trials in US and EU

Developed and implemented Quality Systems to adhere to GMP standards

IRX Therapeutics, Director of Quality Assurance

Managed day-to-day operations and staff of the quality assurance department

Reviewed and approved all validation documents, including test method validation, equipment and facilities validation and process validation, SOPs, change controls, batch records, etc.

Developed and implemented internal and external audit programs

Developed and implemented Qualification program for the raw material suppliers and contractors

Pfizer Global Manufacturing, Pharmaceutical Product Assurance Senior Release Specialist

Responsible for site pharmaceutical products release

Provided key QA support for the new product launches involving contract manufactured products

Performed internal quality assurance audits

Performed process, equipment, cleaning and packaging validations