Qualification Specialist

BSP Pharmaceuticals S.r.l.; Mostacciano; Hybrid; EUR 40,000 - 56,000; Full time

Job summary

BSP Pharmaceuticals S.p. A in Italy is seeking a Qualification Specialist to ensure rigorous documentation and validation activities for equipment and utilities in a high containment plant.

You will lead analysis of technical documentation, draft and review DQ/IQ/OQ/PQ protocols, and generate qualification reports to meet GMP-compliant standards. The role emphasizes collaboration with purchasing for bid analyses and adherence to company procedures, with a focus on sterile environments.

Qualifications

• Master's degree in chemical engineering/CTF/chemistry.
• Knowledge of regulations for Equipment and Utilities validation, especially sterile departments.
• At least 2 years of experience in a similar qualification role in complex organizations.

Responsibilities

• Analyze technical documentation.
• Ensure analysis and evaluation of technical documentation related to equipment and utilities to be qualified, to define protocols and execution of qualification activities per procedures.
• Draft qualification documents (Risk Assessments, DQ-IQ-OQ-PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan).
• Prepare Qualification Reports (DQ-IQ-OQ-PQ Reports) based on data from validation activities in compliance with procedures.

Skills

Equipment and Utilities validation知识

Education

Master's Degree in Chemical Engineering/CTF/Chemistry

Job description

BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains 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.

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

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.