Experienced Validation Scientist with a demonstrated history of working in the pharmaceuticals industry. Skilled in Pharmaceutics, Good Practices (ie, GMP, GLP, GVP…), Medical Devices, Solid/Liquid Oral Dose, Injectable/ophthalmic, Ointments (ie, wide experience of products and types), Quality Assurance, Quality Control, Regulatory compliance, and Validation. Strong Scientific professional with a Bachelor's degree focused in Biology and Psychology from State University of New York at Albany. Psychology is a science based upon good study design and statistical power.I expect the industry to grow in the next few years and to quote, the guide to cleaning validation for consumer safety officers (7/93), by the FDA, “It is not unusual to see manufacturers use extensive sampling and testing programs following the cleaning process without ever really evaluating the effectiveness of the steps used to clean the equipment.” There is an expectation of Science being the key word in ensuring sufficient detail (ie 211.67). If you want further reading, try USA FDA vs. Barr labs (circa 1994). My experience with Barr Labs still surpasses the industries’ standards and helped make me the source of knowledge I am today.
Listed skills include Validation, Pharmaceutical Industry, Fda, 21 Cfr Part 11, and 45 others.