Position Details
REPORTS TO
MFA/API Quality Operations Global Platform Lead
The Quality Assurance Lead/QP is responsible for ensuring quality, rigorously adhering to cGMP and Phibro standards. The Quality Assurance Lead will be responsible for overseeing the management of non-quality events, ensuring that qualification and validation processes meet regulatory and internal standards, and maintaining data integrity across all operations and projects. In addition, he/she will play a crucial role in fostering a culture of continuous improvement and a quality mindset throughout the organization. This includes supporting the growth and development of team members, promoting collaboration across various functions, and driving initiatives to enhance processes and outcomes.
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
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
Manage deviations (generation, investigation, impact, reporting and approval)
Review of Quality Control out of specification results and investigations
Ensure the execution of periodic report (Product Quality Review) on the manufactured products and the GMP self-inspection
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 release each manufacturing batch according to D.Lgs 219/06 and register each batch in the site’s logbook for the regulatory inspection
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
Fluent in spoken and written English and Italian
To learn more about Phibro Animal Health's competitive benefits package, please click here: .