Qualification Specialist in Sterile Equipment Validation

BSP Pharmaceuticals S.r.l.; Mostacciano; Ibrido; EUR 40.000 - 56.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Equipment and Utilities validation知识

Formazione

Master's Degree in Chemical Engineering/CTF/Chemistry

Descrizione del lavoro

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.