Quality Assurance Specialist

BSP Pharmaceuticals S.p.A focuses on developing and manufacturing potent anticancer drugs with high cytotoxic characteristics for the pharmaceutical industry.

The company has been at the forefront in the fight against cancer since its inception, driven by innovation and investments in new technologies and production methods in a high-containment plant.

BSP is one of the most important Contract Development and Manufacturing Organizations (CDMOs) for anticancer drugs.

We are currently seeking a Quality Assurance Specialist who will primarily ensure :

• Analysis of technical documentation
• Definition of qualification documents
• Qualification and validation activities

Main Activities :

• Analysis of Technical Documentation : Ensure the analysis and evaluation of technical documentation related to equipment and utilities to be qualified, acquiring necessary information for protocol definition and execution.
• Definition of Qualification Documents : Draft qualification documents (Risk Assessment, DQ-IQ-OQ-PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan), researching data from other corporate functions to define contents and settle qualification strategy.
• Qualification : Ensure proper qualification of equipment and utilities within required time frames, executing operational activities provided in protocols (DQ-IQ-OQ-PQ Protocols).
• Qualification Reports : Prepare Qualification Reports (DQ-IQ-OQ-PQ Reports) based on validation activity data, in compliance with company protocols and procedures.

Main Requirements :

• Master's Degree in Chemical Engineering / CTF / Chemistry
• Regulatory Knowledge : Familiarity with regulations regarding Equipment and Utilities validation, especially in sterile departments
• Experience : At least 2 years in same role in complex organizations

BSP values diversity, different backgrounds, and experiences, providing equal opportunities for all employees.

Quality Assurance Specialist • Latina, IT