17 ago
|
Phibro Animal Health
|
Medolla
17 ago
Phibro Animal Health
Medolla
The Quality Manager is an integral part of our Quality team based out of our Medolla, Italy site. Responsibilities * Site Quality responsibility to provide technical expertise & leadership for Quality & compliance topics/issues. * Provide strategic guidance with management related to QA operations, approaches to deviation investigations & improvements to ensure robust performance. * Ensure schedules for review & approval of GMP documents are developed & maintained to meet the commercial supply timelines. * Provide sound support to operations, engineering, supply chain & material movement for commercial products. * Ensure relevant QA documents & procedures are approved to schedule to support technology transfers & NPIs. * Provide strategic leadership for deviation investigations, including root cause analysis & corrective & preventive action proposals & initiatives. * Lead QA review & approval of SOPs, batch process records, policies, validation protocols & reports. * Develop objectives for the QA department & direct reports,
monitor performance & progress against departmental objectives & prepare performance reviews & development plans for direct reports. * Provide support & expertise for the preparation of regulatory submissions, inspection readiness activities during health authority inspections including leading audits with inspectors, responses to inspection observations & monitoring progress of follow up actions. * Support audits of GMP material suppliers & Providers executed according to PAHC Supplier Management/audit program. Provide support for improvement & follow up CAPAs. * Conduct work activities in compliance with Safety, Health and Welfare at Work legislation & Company policies. * Other duties as assigned. Competencies * Have achieved a satisfactory level of technical & professional skill/knowledge in position related areas, keep up with current developments & trends. * Strong technical knowledge as it applies to QMS, QA & related regulatory requiremen
📌 Quality Manager (Medolla)
🏢 Phibro Animal Health
📍 Medolla