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