Tim Fields

A skilled professional with practical experience and strong knowledge in pharmaceutical quality operations including laboratory, validation, sterilization, aseptic operations, computer system validation, electronic records and signatures, quality systems, auditing, Good Manufacturing Practices (GMP) training, procedure and policy preparation, and regulatory inspections. Knowledgeable in various international pharmaceutical regulations. Experienced in sterile and non-sterile drug products and APIs. Able to take charge and lead teams as well as work independently to accomplish goals. Strong presentation and writing skills. Able to communicate at multiple organizational levels. I focus on pragmatic solutions that improve the system and do not just address the symptoms. Specialties: Compliance expertise particularly in quality management systems, validation documentation, GMP compliance auditing, GMP Training, SOP development, quality standards, computer system validation, and Part 11 compliance.