For important Company our client we are looking for a qualification specialist

Key Responsibilities

• Coordinate qualification activities for facilities, utilities, equipment, classified areas, and

critical systems supporting sterile biologics Fill & Finish operations, in compliance with GMP

requirements.

• Prepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ,

qualification protocols, and final reports, in accordance with internal procedures and regulatory

expectations.

• Act as a witness during on-site qualification and testing activities performed by external vendors

and contractors.

• Interface and coordinate qualification activities with Engineering, Production, Quality

Assurance, Maintenance, MSAT, and HSE functions within a CDMO environment.

• Support qualification planning and contribute to budget estimation and tracking for the

assigned area.

• Provide support during internal audits, client audits, and regulatory inspections (EMA, FDA),

including periodic review of qualified systems.

• Ensure data integrity, traceability,



and compliance of all qualification-related documentation

and records.

• Collaborate with equipment and system suppliers for technical documentation collection and

execution of qualification activities.

• Monitor the qualification status and lifecycle management of assets, ensuring ongoing

compliance throughout their operational life.

Minimum Requirements

• Bachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry,

Biotechnology, Engineering, Pharmacy).

• 2–3 years of experience in qualification and/or validation roles within pharmaceutical or

biotechnology manufacturing environments, preferably in CDMO organizations.

• Solid knowledge of GMP and relevant international regulatory standards (EMA, FDA).

• Proven experience in the preparation and management of GMP documentation in regulated

environments.

• Essential hands-on experience gained in pharmaceutica

📌 Qualification specialis (Roma)
🏢 Randstad Enterprise Italia
📍 Roma