Validation Specialist (Csv - Data & Compliance)

Productlife Group; Italia; In loco; EUR 35.000 - 45.000; Tempo pieno

Descrizione del lavoro

Productlife Group seeks an experienced CSV validation professional in Italy to plan, coordinate, and execute computerized system validation for client projects, ensuring compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11. You will manage validation documentation, perform risk assessments, and support regulatory inspections.

Ideal candidates have 4-5 years of experience, strong data integrity knowledge, and fluency in Italian and English.

Competenze

• Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
• 4-5 years of experience in CSV validation or a similar field.
• Fluency in Italian and English is required.

Mansioni

• Plan, coordinate and execute CSV activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11 and 21 CFR Part 11.
• Prepare, review and manage validation documentation including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ, and Validation Reports.
• Support Data Integrity compliance per ALCOA+ and regulatory requirements.
• Perform risk assessments to define validation strategies and ensure regulatory compliance.
• Support Change Control, Deviations, CAPAs and validation lifecycle activities for computerized systems.
• Collaborate with QA, IT, Engineering, Manufacturing, QC and Validation to deliver projects.
• Assess impact of software implementations and changes on validated systems.
• Draft and update SOPs, VMPs and GMP documentation for client projects.
• Provide validation support during internal and supplier audits and regulatory inspections.
• Contribute to multiple projects ensuring delivery within timelines and quality standards.

Conoscenze

Italian

English

Formazione

Bachelor's or Master's degree in Engineering/CS/IT/Life Sciences/Pharmacy/Chemistry/Biotechnology

Strumenti

Microsoft Office Suite

Descrizione del lavoro

Specific activities and responsibilities:

• Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.
• Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.
• Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements.
• Perform risk assessments to define validation strategies and support regulatory compliance.
• Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems.
• Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects.
• Assess the impact of software implementations, upgrades, and changes on validated systems.
• Draft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects.
• Provide validation and compliance support during internal audits, supplier audits, and regulatory inspections.
• Contribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations.

Required education:

Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field

Required experience :

4-5 years of experience

Required languages:

Italian and English

Required technical skills:

• Knowledge of GxP regulations and GMP requirements applicable to computerized systems.
• Good understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
• Experience with Computerized System Validation (CSV) lifecycle and validation methodologies.
• Understanding of software development lifecycle (SDLC) and computerized systems lifecycle management.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Additional experience and/or skills:

• Attention to detail
• Team working and proactivity
• Problem solving
• good Interpersonal skills
• customer management
• team management
• availability to travel is mandatory

Compensation range: €35000 - €45000

The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements.