Copy of CSV Consultant (Lombardia)

fortil; Frosinone; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading engineering and technology consulting firm is seeking a CSV Consultant to validate and support computerized systems in the Life Sciences sector. The ideal candidate has a relevant degree and over 3 years of experience in CSV projects, demonstrating compliance with regulations like GMP and CFR 21 Part 11. The role fosters growth and includes unique opportunities for skill enhancement and involvement in community projects.

Servizi

Personalized support for skill growth

Opportunities to become a shareholder

Involvement in community projects

Support parenthood policies

Competenze

• 3+ years of experience on CSV projects in the Life Science field.
• Knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5.
• Knowledge of data integrity regulations and guidelines.

Mansioni

• Validate computerized systems in the Life Science sector.
• Support remediation or requalification projects.
• Draft and execute validation documents and test protocols.

Conoscenze

Data flow mapping

Gap analysis

Compliance knowledge

Office package

English (written and spoken)

Formazione

Bachelor's or Master's degree in technical-engineering or similar

Descrizione del lavoro

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Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.

We are looking for a CSV Consultant for a strategic project.

Location: Lazio

Responsibilities

• Validation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines);
• Support in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines;
• Periodic review of computerized systems and user audit trails;
• Drafting of validation documents: Validation Plans, URS, Traceability Matrices;
• Drafting and execution in the field of test protocols: IQ/OQ/PQ;
• Drafting of Risk Assessments;
• Drafting of computerized system administration procedures;

About You

• Bachelor's or Master's degree in technical-engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology);
• 3+ years of experience on CSV projects in the Life Science field;
• Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities;
• Good knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required;
• Good knowledge of the English language, both written and spoken;
• Excellent knowledge of the Office package;

Why join us?

• Personalized support to help you grow your skills;
• An ecosystem that encourages you to step outside your comfort zone;
• The opportunity to become a shareholder;
• Involvement in community and non-profit projects;
• A dedicated policy to support parenthood;

Fortil is committed to equal opportunity. All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation.