John Quiles Email & Phone Number

President of JQCS Consulting, Senior Validation Engineer and Cleaning Validation Subject Matter Expert (SME) with more than twenty (20) years of extensive experience in regulated industries such as Pharmaceutical, Biotechnology and Medical Device industries, as well as OTC, Cosmetic and Consumer Products. Successfully lead teams of validation professionals. Experience includes vast experience with Commissioning and Qualification for multiple types of process equipment and utilities, as well as extensive cleaning validation experience in biologics, pharma, medical device, OTC, cosmetic and consumer industries. Cleaning Validation SME with vast CIP, COP, Manual Cleaning, and SIP experience. Wide documentation development and review experience, including equipment qualification documentation (IQ, OQ, PQ), engineering and design specifications, P&ID, deviations/discrepancies, process validations protocols and reports, SOPs, periodic reviews, strategies, and Master Plans among others. Experienced working under remediation and consent decree environments helping them to meet compliance requirements. Strong communication and teamwork skills always exceeding expectations in a safe and ethical manner. Received two “Best in Class” VP Manufacturing Awards (J&J); one for the construction and implementation of the new Ethicon CME building (Core team), and another one for the development, validation and implementation of the new Coating and Inspection line (Validation Project Lead).

Listed skills include Validation, Cleaning Validation, Fda, Gmp, and 43 others.