Iris Shamir, M.Sc.

VP Pharma Quality and Medical Device at Gsap

Former GMP inspector at the Pharmaceutical Inspection Division of the Israeli Ministry of Health’s Institute for Standardization and Control (ISCP).

She served as a lead inspector in audits of laboratories, active pharmaceutical ingredient (API) manufacturers, dry production, semi-solid and liquid dosage forms, as well as wholesalers and importers.
Iris participated as an inspector in audits of aseptic and sterile processes, biotechnological products, and advanced therapy medicinal products (ATMPs).

Iris has over 25 years of experience in the pharmaceutical and medical device industries, including combination products, in various roles in quality assurance, quality control, and compliance.
She has managed large quality organizations and led numerous manufacturing sites to successful inspections by the FDA and other regulatory authorities.
She has conducted dozens of supplier audits at API and finished product manufacturing sites in India, China, the U.S., and Europe.

Cleaning validation and cross-contamination control Expert.