Dorothy Sobczyk Email & Phone Number

Quality director with demonstrated success in developing/delivering results by re-engineering laboratory systems to reduce both risk and cost, with key objectives to increase organizational reliability and product development. Extensive experience in diverse, regulated industries including parenteral drugs, solid dosage forms, liquids, ointments, creams, suspensions and suppositories. Successfully managed a variety of Quality Control, Compliance, Validation and Analytical R&D functions, based upon a thorough understanding of FDA, EMA, ISO, ICH and GxP regulations and requirements. Effectively interfaces with customers, corporate management, regulatory entities, and laboratory personnel to achieve maximum efficiencies.

Listed skills include Validation, Fda, Gmp, Gxp, and 16 others.