Quality Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b6r6p

ppThe Quality Manager is an integral part of our Quality team based out of our Medolla, Italy site. /p h3Responsibilities /h3 ul liSite Quality responsibility to provide technical expertise leadership for Quality compliance topics/issues. /li liProvide strategic guidance with management related to QA operations, approaches to deviation investigations improvements to ensure robust performance. /li liEnsure schedules for review approval of GMP documents are developed maintained to meet the commercial supply timelines. /li liProvide sound support to operations, engineering, supply chain material movement for commercial products. /li liEnsure relevant QA documents procedures are approved to schedule to support technology transfers NPIs. /li liProvide strategic leadership for deviation investigations, including root cause analysis corrective preventive action proposals initiatives. /li liLead QA review approval of SOPs, batch process records, policies, validation protocols reports. /li liDevelop objectives for the QA department direct reports, monitor performance progress against departmental objectives prepare performance reviews development plans for direct reports. /li liProvide 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. /li liSupport audits of GMP material suppliers Providers executed according to PAHC Supplier Management/audit program. Provide support for improvement follow up CAPAs.



/li liConduct work activities in compliance with Safety, Health and Welfare at Work legislation Company policies. /li liOther duties as assigned. /li /ul h3Competencies /h3 ul liHave achieved a satisfactory level of technical professional skill/knowledge in position related areas, keep up with current developments trends. /li liStrong technical knowledge as it applies to QMS, QA related regulatory requirements. /li liAn understanding of EU GMP, ICH, HACCP (Feed Safety Risk Assessment/Management) and compendia regulations guidance for Veterinary Medicinal Products Feed Additives. /li liProven ability to manage complex quality issues, direct cost, effective quality programs deliver against Quality metrics. /li liIdentify understand issues, problems opportunities compare data to draw conclusions develop solutions consistent with the facts. /li liAbility to form strong relationships cross functionally. /li liAlways be aware of conditions that affect employees product safety. /li liSet high standards of performance; assume responsibility accountability for successfully completing assignments/tasks. /li /ul h3Education Experience /h3 ul liAdvance degree (Masters, PhD) in a technical discipline (e.g. biochemistry, chemistry,



pharmacy) minimum of 7 years’ experience in a GMP Quality environment with a minimum of 3 years in a managerial role: or equivalent combination of education experience is required. /li liQP Eligibility Experience Of Releasing Batches Is Required. /li liMinimum of 7 years’ relevant experience within a pharmaceutical (preferably Veterinary) industry/related field is desirable. /li liMinimum of 3 years’ experience as a named QP for manufacture of commercial medicines is desirable. /li liDemonstrated success records in leading regulatory audits is desirable. /li liIn depth knowledge of current regulatory requirements for manufacturing technology in support of GMP operations supporting commercial manufacturing is desired. /li liDirect experience of GMP management within a pharma/biopharma company is essential will include exposure to Health Authority inspections/audits certifying 3rd party organizations desirable. /li liDemonstrated success in quality management the resolution significant quality/technical challenges desirable. /li /ul h3Equal Opportunity Employer /h3 pbPhibro is an Equal Opportunity Employer /b /p pAll qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law. /p h3Business Unit /h3 pAnimal Health Mineral Nutrition /p h3Department /h3 pQuality /p h3Work Schedule /h3 pMonday - Friday (40 Hours) /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b6r6p