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: €40000 – €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.

Validation Specialist (Data & Compliance)

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