Quality Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hubs7

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 requirements.
An understanding of EU G

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hubs7