Validation Specialist

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

Vantaggi offerti da questo lavoro

Travel required

Descrizione del lavoro

Productlife Group in Italy is seeking an SDS Specialist – Autonomous Vehicle Diagnostics Calibration to lead CSV validation activities for client projects, ensuring compliance with GxP, GMP, EU GMP Annex 11, and 21 CFR Part 11. The role requires 4–5 years of experience, Italian and English language skills, and willingness to travel.

You will draft validation documentation, support audits, and collaborate across QA, IT, Engineering, Manufacturing, and Validation teams to deliver compliant

Competenze

• Knowledge of GxP regulations and GMP requirements for computerized systems.
• Experience with CSV lifecycle and validation methodologies.
• Understanding of SDLC and lifecycle management of computerized systems.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Italian and English language skills are mandatory.

Mansioni

• Plan, coordinate, and execute CSV activities for client projects compliant with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11.
• Prepare and manage validation documentation including Validation Plans, IQ/OQ/PQ, and Validation Reports.
• Support data integrity and ALCOA+ principles in regulatory contexts.
• Assess software implementations' impact on validated systems and support lifecycle activities.
• Draft and update SOPs and Validation Master Plans; participate in internal and supplier audits.

Conoscenze

GxP regulations

GMP

GAMP 5

EU GMP Annex 11

21 CFR Part 11

CSV lifecycle

SDLC

MS Office

Regulatory compliance

Cross-functional collaboration

Formazione

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

Strumenti

Validation documentation tools

Descrizione del lavoro

SDS Specialist – Autonomous Vehicle Diagnostics Calibration

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.