Qualification Specialist

BSP Pharmaceuticals S.p.A.; Latina; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceuticals company in Italy is seeking a Qualification Specialist responsible for the analysis and execution of qualification activities for equipment and utilities. This role requires a Master's Degree in a relevant field, at least 2 years of experience, and knowledge of regulations for Equipment and Utilities validation. The ideal candidate will have proficiency in English and a proactive approach. The company promotes an inclusive workplace fostering collaboration and innovation.

Competenze

• Master's Degree in a relevant field.
• Knowledge of regulations for Equipment and Utilities validation.
• At least 2 years in a similar role within complex organizations.
• Proficiency in English is required.
• A can-do attitude is essential.

Mansioni

• Ensure analysis, definition and execution of qualification activities.
• Evaluate technical documentation to acquire information for qualification protocols.
• Draft qualification documents including Risk Assessment and Validation Plans.
• Perform qualification of required equipment within specified time frames.
• Prepare Qualification Reports based on validation activities.

Conoscenze

Technical Documentation Analysis

Qualification Document Definition

Qualification Execution

Report Preparation

English language proficiency

Formazione

Master's Degree in Chemical Engineering, Chemistry or related field

Descrizione del lavoro

Overview

BSP Pharmaceuticals S.p. A specializes in the development and manufacturing of high‑potency anticancer drugs. Since 2006, BSP has led the fight against cancer, investing in advanced technologies and a high‑containment production plant. As a leading CDMO, BSP delivers contract development and manufacturing services for anticancer therapeutics.

Responsibilities

Qualification Specialist – ensure the analysis, definition and execution of qualification activities for equipment and utilities.

• Technical Documentation Analysis – evaluate technical documentation to acquire information for qualification protocols.
• Qualification Document Definition – draft qualification documents (Risk Assessment, DQ‑IQ‑OQ‑PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan).
• Qualification Execution – perform qualification of equipment and utilities within required time frames, formulate bid requests with the Purchasing function, and support technical and economic bid analyses.
• Qualification Report Preparation – prepare Qualification Reports (DQ‑IQ‑OQ‑PQ Reports) based on data from validation activities.

Qualifications

• Master's Degree in Chemical Engineering, Chemistry or related field.
• Knowledge of regulations for Equipment and Utilities validation, especially for sterile departments.
• At least 2 years of experience in a similar role within complex organizations.
• English language proficiency.
• Can‑do attitude.

Benefits

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, empowering our people to unleash their full potential. We respect diversity, provide equal opportunity for all, and celebrate collaboration.