Qualification Specialist

BSP Pharmaceuticals S.p.A.; Latina; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

BSP Pharmaceuticals S.p.A. is seeking a Qualification Specialist to ensure qualification activities for equipment and utilities, drafting validation protocols and reports in a GMP environment.

The role focuses on analyzing technical documentation, defining qualification documents, and coordinating supplier bids to support qualified state systems. The ideal candidate holds a Master’s degree in Chemical Engineering, chemistry, or related fields, with at least two years of experience in a similar

Qualifikationen

• Master's degree in a relevant field or equivalent
• Knowledge of regulations regarding Equipment and Utilities validation, especially sterile departments
• At least 2 years of experience in the same role within complex organizations
• Proficiency in English required
• Demonstrated can-do attitude and proactive problem solving

Aufgaben

• Analyze technical documentation to support qualification activities
• Draft and coordinate qualification documents (DQ-IQ-OQ-PQ, VMP, Validation Plans) and gather data from other functions
• Ensure qualification of equipment and utilities within required timelines, assisting with bid requests and supplier evaluations
• Prepare Qualification Reports based on validation data in line with company procedures

Kenntnisse

English

Can-do attitude

Ausbildung

Master's Degree in Chemical Engineering/CTF/Chemistry

Jobbeschreibung

BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. The fight against cancer is ours too.

Posizione

We are currently looking for a Qualification Specialist - that will mainly ensure:

Main Activities

Analysis of technical documentation

Ensure the analysis and evaluation of technical documentation related to equipments and utilities to be qualified, in order to acquire information necessary for the definition of protocols and the execution of qualification activities in compliance with company procedures;

Definition of qualification documents

Ensure the drafting of qualification documents (Risk Assessment, DQ-IQ-OQ-PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan), by researching and acquiring from other corporate functions the data and information necessary to define their contents and to settle the qualification strategy;

Qualification

Ensure within the required tiem frame the proper qualification of equipments and utilities, through the execution of the operational activities provided for in the Protocols (DQ-IQ-OQ-PQ Protocols). In collaboration with the Purchasing function, formulate bid requests to suppliers and support the Manager, preparing a technical and economic analysis of the bids received;

Qualification Reports

Ensure the proper preparation of Qualification Reports (DQ-IQ-OQ-PQ Reports), based on the analysis of data generated from validation activities, in compliance with company protocols and procedures;

Main Requirements

• Master's Degree in Chemical Engineering/CTF/Chemistry
• Knowledge of regulations regarding Equipment and Utilities validation, with particular reference to sterile departments
• At least 2 years of experience in the same role in complex organizations
• English
• Can-do attitude

Altre informazioni

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

We are BSP.