Qualification Specialist - Sterile Pharma CDMO

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 45,000 - 65,000; Full time

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

English

Can-do attitude

Education

Master's Degree in Chemical Engineering/CTF/Chemistry

Job description

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