Senior CSV Validation Specialist - Life Sciences | Remote

MAASI Enterprises Ltd; Imola; Ibrido; EUR 32.000 - 54.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working hours

Remote working

Training programs

Performance bonuses

Team building activities

Health insurance

Descrizione del lavoro

MAASI Enterprises seeks a Mid- to Senior CSV Specialist (Computerised System Validation) to provide consulting in Life Sciences. You will define validation strategies for complex computerised systems, ensuring regulatory compliance and Data Integrity throughout the lifecycle, and act as a reference for stakeholders.

You’ll coordinate project activities, oversee Change Control and Periodic Reviews, and collaborate with cross-functional teams.

Competenze

• Proven consultancy experience in the Life Sciences sector.
• Strong knowledge of GxP, GAMP 5, FDA 21 CFR Part 11 and EudraLex Annex 11.
• Experience in preparing and reviewing regulated documentation.
• Excellent organization and prioritization across complex projects.
• Excellent interpersonal and communication skills; liaising with cross-functional teams.
• Fluency in English and Italian (C1+).

Mansioni

• Define validation strategies and manage Change Control and Periodic Reviews for computerised systems.
• Conduct Impact and Risk Assessments (GAMP / Data Integrity) and develop IT/OT qualification plans.
• Prepare and approve validation documentation, including Validation Plans, Validation Reports, URS, FS and DS.
• Develop and support the execution of tests for Commissioning, FAT/SAT and IQ/OQ/PQ protocols.
• Prepare and maintain SOPs, Work Instructions and related training plans.

Conoscenze

Life Sciences consultancy

Excellent communication

Multidisciplinary collaboration

Fluent English and Italian

Strong organizational skills

Strumenti

GAMP 5

FDA 21 CFR Part 11

EudraLex Annex 11

Descrizione del lavoro

MAASI Enterprises seeks a Mid- to Senior CSV Specialist (Computerised System Validation) to provide consulting in Life Sciences. You will define validation strategies for complex computerised systems, ensuring regulatory compliance and Data Integrity throughout the lifecycle, and act as a reference for stakeholders.

You’ll coordinate project activities, oversee Change Control and Periodic Reviews, and collaborate with cross-functional teams.