Quality Manager (Medolla)

Quality Manager (Medolla)

01 ago
|
PHIBRO ANIMAL HEALTH
|
Medolla

01 ago

PHIBRO ANIMAL HEALTH

Medolla

ph3Overview /h3 pPhibro Animal Health Corporation is a publicly traded global company that manufactures and markets medicated feed additives, vaccines, nutritional specialty products and mineral nutrition products for livestock and companion animals. It supports producers, farmers, veterinarians and consumers worldwide. /p h3Responsibilities /h3 ul liProvide technical expertise and leadership for Quality compliance topics/issues within the Quality team at the Medolla, Italy site. /li liOffer strategic guidance related to QA operations, deviation investigations and performance improvement to ensure robust results. /li liDevelop and maintain schedules for GMP document reviews and approvals to meet commercial supply timelines. /li liSupport operations, engineering, supply chain and material movement for commercial products. /li liApprove QA documents and procedures to support technology transfers and new product introductions. /li liLead root cause analysis and corrective and preventive action proposals for deviation investigations. /li liReview and approve SOPs, batch process records, policies, validation protocols and reports. /li liSet objectives for the QA department; monitor performance against objectives; prepare performance reviews and development plans for direct reports. /li liProvide expertise for regulatory submissions and inspection readiness, including leading audits with health authority inspectors, responding to observations and monitoring follow‑up actions. /li liSupport audits of GMP material suppliers and providers according to PAHC Supplier Management/audit program. /li liEnsure compliance with Safety, Health and Welfare at Work legislation and company policies. /li liPerform other duties as assigned. /li /ul h3Competencies /h3 ul liAttain a satisfactory level of technical and professional skill in QMS, QA and regulatory requirements. /li liDemonstrate strong technical knowledge of QMS, QA and regulatory requirements. /li liUnderstand EU GMP, ICH, HACCP (Feed Safety Risk Assessment/Management)



and compendia regulations for veterinary medicinal products and feed additives. /li liProven ability to manage complex quality issues, direct costs, effective quality programs and achieve quality metrics. /li liIdentify issues, problems and opportunities; analyze data and develop solutions consistent with facts. /li liBuild strong cross‑functional relationships. /li liMaintain awareness of conditions affecting employee and product safety. /li liSet high standards of performance; assume responsibility and accountability for successful completion of tasks. /li /ul h3Education Experience /h3 ul liAdvanced degree (Master’s, PhD) in a technical discipline (e.g., biochemistry, chemistry, pharmacy) with a minimum of 7 years’ experience in a GMP quality environment, including at least 3 years in a managerial role. /li liQP eligibility and experience releasing batches. /li liMinimum of 7 years’ relevant experience in the pharmaceutical (preferably veterinary) industry or related field. /li liMinimum of 3 years’ experience as a named QP for manufacture of commercial medicines. /li liDemonstrated success leading regulatory audits. /li liIn‑depth knowledge of current regulatory requirements for manufacturing technology supporting GMP operations for commercial manufacturing. /li liDirect experience in GMP management within a pharma/biopharma company, including exposure to Health Authority inspections, audits and certification of third‑party organizations. /li liTrack record of resolving significant quality/technical challenges. /li /ul h3Equal Opportunity Employer /h3 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 characteristic protected by law. /p h3Location Work Schedule /h3 pbBusiness Unit: /b Animal Health Mineral Nutritionbr/bDivision: /b Animal Health Nutritionbr/bDepartment: /b Qualitybr/bLocation: /b Medolla, Italybr/bWork Schedule: /b Monday - Friday (40 Hours) /p /p #J-18808-Ljbffr

📌 Quality Manager (Medolla)
🏢 PHIBRO ANIMAL HEALTH
📍 Medolla

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