Complete requirements are as followsbr Masters degree in pharmaceutical Sciences, Biotechnology, Mechanical or Biomedical Engineering or a related field, and 2 years of experience in quality engineering.br br Must also possess a minimum of two years of experience with each of the following Medical Device or drugdevice Combination product manufacturing; cGMPs, United States Pharmacopeia, and International Council for Harmonisation; FDA 21 CFR Parts 4, 11, 210, 211, and 820; ISO 14644, ISO 13485, and ISO 14971; CAPA and equipment and process validations IQOQPQ using Process Characterization, process changes, and product nonconformance evaluations; DOE, risk evaluation, test method validation, Measurement System Analysis, methodical problem solving, statistical analysis, and Gap Assessment and Remediation; Risk Mgmt. and Analysis FMEA for Pre and Post market products.

Categories: eb3

0 Comments

Leave a Reply

Avatar placeholder

Your email address will not be published. Required fields are marked *