Quality Assurance Supervisor

Phibro Llc; Italia; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Phibro Llc cerca un Quality Assurance Supervisor per il sito di Medolla, Italia, con responsabilità di supervisione quality, conformità GMP e gestione ispezioni.

La posizione richiede Master in disciplina tecnica, 5 anni di esperienza, conoscenza di GMP e capacità di gestione deviazioni e audit. Si valorizza esperienza come Qualified Person e competenze linguistiche inglese/italiano.

Competenze

• Master's degree in field tecnico-scientifico; Esame di stato richiesto.
• Minimo 5 anni di esperienza in ruolo simile, idealmente in facility farmaceutica.
• Conoscenza approfondita di GMP e sistemi di gestione della qualità.
• Esperienza con ispezioni normative, clienti e ispezioni interne.
• Idoneità al ruolo di Qualified Person.

Mansioni

• Monitorare efficacemente i processi di produzione secondo standard Phibro e direttive EU.
• Eseguire report di Product Quality Review e self-inspection GMP.
• Gestire deviazioni dall’individuazione alla chiusura e approvazione.
• Revisionare i risultati QC fuori specifica e le relative indagini.
• Coordinare audit con Autorità Regolatorie e sanitari.
• Garantire che SOP e documenti rispettino GMP e sistemi di qualità Phibro.

Conoscenze

GMP regulations

Quality management

Audits

Root cause analysis

English proficiency

Italian proficiency

Formazione

Master's degree in technical-scientific field

Esame di stato

Descrizione del lavoro

Quality Assurance Supervisor

Azienda : Phibro Llc Tipo Lavoro : Full Time Italy JobCopilot will tailor your resume and auto-fill the application

Descrizione Lavoro - Quality Assurance Supervisor

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,400 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

TheQuality Assurance Supervisoris an integral part of our Quality Assuranceteam based out of our Medolla, Italysite.

Position Details

EDUCATION
Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy)
Esame di stato is required
EXPERIENCE
Minimum of 5 years’ experience in a similar role, ideally in a pharmaceutical manufacturing facility
Strong knowledge of GMP regulations and quality management systems
Experience with regulatory, client and self-inspections audits
Eligible for Qualified Person role
RESPONSIBILITIES
Ensure effective monitoring of production processes according to European and Phibro Quality Standards and EU directives and regulations
Ensure the execution of periodic report (Product Quality Review) on the manufactured products and the GMP self-inspection
Manage deviations (generation, investigation, impact, reporting and approval)
Review of Quality Control (QC) out of specification results and investigations
Review of quality acceptance criteria for raw materials, intermediates products, and finished products
Coordinates and manage periodic audit with Regulatory and Health Authorities
Ensure that all SOPs and other related documents follow GMP and Phibro Quality Systems. He/she is responsible for site GMP documentation control
Provide quality direction and manage the implementation of changes for critical company systems, according to the "change control" procedure
Manage deviations and non-conformities, ensuring the quality of the finished product and verifying the efficacy of the relative corrective actions
Manage customer complaints with related investigation, corrective activities, response and complaint closure
Coordinate the activities to support the management of supplier qualification and approve the related Quality Agreement (where necessary)
Review and approve qualification/validation protocols and reports
Knowledge of root cause analysis methodology and Quality Risk Management
Collaborates in the supervision of the general hygiene conditions of the premises and pest monitoring activities for which he/she is responsible
Provide information for, and complete, as necessary customer by mail surveys, audits, and inquiries
As Qualified Person, the quality assurance lead is responsible to ensure compliance with Regulation (EU) 2019/6 on veterinary medicinal products, applicable EU GMP requirements, marketing authorizations, manufacturing authorizations, and relevant national implementing legislation.
Provide quality oversight of feed additive manufacturing activities and ensure compliance with applicable feed and feed-additive regulations, site licenses, and quality standards.
Ensure appropriate segregation between veterinary medicinal product GMP activities and feed additive quality requirements where applicable.
CORE COMPETENCIES
Excellent problem-solving and decision-making skills
Good team building and collaboration both on-site and with teams remotely
Promote a culture of continuous learning and development for the site quality organization
Improve on-site understanding of GMP’s through good quality programs, procedures, and training
Ability to prioritize different activities and manage multiple projects
Strong communication skills
Fluent in spoken and written English and Italian

Phibro is an 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 characteristics protected by law.

Business Unit:Animal Health & Mineral Nutrition
Division:Animal Health & Nutrition
Department:Quality Assurance
Location:Medolla, Italy
Work Schedule:Monday - Friday (40 Hours)