Knowledge and Skill: Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system. Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.