02 ago
|
Medicina
|
Medolla
Overview
Phibro 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.
Responsibilities
Provide technical expertise and leadership for Quality & compliance topics/issues within the Quality team at the Medolla, Italy site.
Offer strategic guidance related to QA operations, deviation investigations and performance improvement to ensure robust results.
Develop and maintain schedules for GMP document reviews and approvals to meet commercial supply timelines.
Support operations, engineering, supply chain and material movement for commercial products.
Approve QA documents and procedures to support technology transfers and new product introductions.
Lead root cause analysis and corrective and preventive action proposals for deviation investigations.
Review and approve SOPs, batch process records, policies, validation protocols and reports.
Set objectives for the QA department; monitor performance against objectives; prepare performance reviews and development plans for direct reports.
Provide expertise for regulatory submissions and inspection readiness, including leading audits with health authority inspectors, responding to observations and monitoring follow‑up actions.
Support audits of GMP material suppliers and providers according to PAHC Supplier Management/audit program.
Ensure compliance with Safety, Health and Welfare at Work legislation and company policies.
Perform other duties as assigned.
Competencies
Attain a satisfactory level of technical and professional skill in QMS, QA and regulatory requirements.
Demonstrate strong technical knowledge of QMS, QA and regulatory requirements.
Understand EU GMP, ICH, HACCP (Feed Safety & Risk Assessment/Management)
and compendia regulations for veterinary medicinal products and feed additives.
Proven ability to manage complex quality issues, direct costs, effective quality programs and achieve quality metrics.
Identify issues, problems and opportunities; analyze data and develop solutions consistent with facts.
Build strong cross‑functional relationships.
Maintain awareness of conditions affecting employee and product safety.
Set high standards of performance; assume responsibility and accountability for successful completion of tasks.
Education & Experience
Advanced 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.
QP eligibility and experience releasing batches.
Minimum of 7 years’ relevant experience in the pharmaceutical (preferably veterinary) industry or related field.
Minimum of 3 years’ experience as a named QP for manufacture of commercial medicines.
Demonstrated success leading regulatory audits.
In‑depth knowledge of current regulatory requirements for manufacturing technology supporting GMP operations for commercial manufacturing.
Direct experience in GMP management within a pharma/biopharma company, including exposure to Health Authority inspections, audits and certification of third‑party organizations.
Track record of resolving significant quality/technical challenges.
Equal Opportunity Employer
All 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.
Location & Work Schedule
Business Unit: Animal Health & Mineral Nutrition
Division: Animal Health & Nutrition
Department: Quality
Location: Medolla, Italy
Work Schedule: Monday - Friday (40 Hours)
#J-18808-Ljbffr
📌 Quality Manager (Medolla)
🏢 Medicina
📍 Medolla