Quality Assurance Medolla

Quality Assurance
Medolla
Emilia Romagna, Medolla

Position DetailsEDUCATION• Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Pharmacy or equivalent)EXPERIENCE• Minimum of 5 years' experience in a similar role, ideally in a pharmaceutical manufacturing facility, with at least 2 years' experience in a managerial role• Strong knowledge of GMP regulations and quality management systems• Experience with regulatory, client and self-inspections audits. • Strong analytical and problem-solving abilities• Eligible for Qualified Person role• Fluent in spoken and written English and Italian 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 (QC) 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. • In-depth knowledge of GMP regulations and pharmaceutical production processes. • Good team building and collaboration while working on teams.

• Generate a culture of continuous learning and development for the site quality organization and provide the site with continuous development of understanding of GMP's through good quality programs, procedures, and training.

• Ability to prioritize different activities and manage multiple projects. • Good communication skills.

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