Qualification Specialist LATINA

Qualification Specialist
Latina
Lazio, LATINA

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 Organizations (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a Qualification Specialist who will mainly ensure the following:

Main Activities:Analysis of Technical Documentation: Ensure the analysis and evaluation of technical documentation related to equipment and utilities to be qualified, in order to acquire necessary information for the definition of protocols and 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 data and information necessary to define their contents and settle the qualification strategy. Qualification: Ensure proper qualification of equipment and utilities within the required time frame, through the execution of 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 by preparing a technical and economic analysis of the bids received. Qualification Reports: Ensure 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/ChemistryKnowledge of regulations regarding Equipment and Utilities validation, particularly in sterile departmentsAt least 2 years of experience in the same role in complex organizationsProficiency in EnglishCan-do attitudeAt BSP, we believe in an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

We respect diversity, different backgrounds, and experiences and provide equal opportunity for all. We are BSP.

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