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Head of Operational Quality

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Assure cGMP compliance for qualification of equipment including Spray Dryers, validation of systems (automation, utilities for Pharmaceutical facilities), manufacturing processes (API & Drug Product Intermediate) & analytical methods. Implement & manage quality systems & tools. Manage audits (internal & external) & regulatory inspections. Ensure site compliance with applicable regulations including 21 CFR 210, 211, EU GMP Guidance Volume 4, ICH Q7 & other applicable ICH guidelines. Support operations in transversal activities. Must have Bachelors in Science (Pharmacy, Chemistry, Food or eq.) or Engineering (Pharmaceutical, Chemical, Food or eq.) & 2 yrs experience with Quality Assurance in API & Drug Product Intermediate environment to include: audits, application of quality requirements, process validation, qualification of spray dryers, ensuring regulatory compliance, & environmental & quality monitoring of clean rooms for manufacture of APIs and Drug Products Intermediate in bulk through Spray Drying technology.