IT Validation Consultant

Excelya; Boulogne-Billancourt; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading company in the life sciences sector is seeking an experienced IT Validation Consultant. This role involves providing validation expertise, ensuring regulatory compliance for computerized systems, and managing a Validation team. Ideal candidates will have a strong background in the pharmaceutical industry and relevant project management experience.

Qualifications

• 2 years experience with CSV validation lifecycle management.
• 1 year project management experience using a risk-based methodology.
• 2+ years experience in the Pharmaceutical manufacturing or Medical Device industry.

Responsabilités

• Provide Validation expertise in strategy and approach.
• Supervise Validation team and manage anomalies.
• Ensure regulatory compliance applicable to computerized systems.

Connaissances

Validation expertise

Regulatory compliance

Risk analysis

Project management

Formation

Bachelor’s degree in computer science, engineering life science or related field

Description du poste

We are looking for an experienced IT Validation Consultant to develop and grow thevalidation client department.

• Provide Validation expertise in Validation strategy and approach
• Ensure regulatory compliance applicable to computerized systems.
• Approve the risk analysis by integrating the regulatory impacts.
• Supervise the Validation team, from planning to the production of the system.
• Approve the Validation plan, the Validation report, each qualification protocol and reports (in accordance with the Validation plan)
• Manage anomalies (if applicable) and approve the action plans put in place
• Approve the production of the IS

Education and Experience

• Bachelor’s degree in computer science, engineering life science or related field
• 2 years experience with CSV validation lifecycle management, validation documentation development and 1 year project management, using a risk based methodology.
• 2 plus years Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions.
• Excellent understanding and experience with industry regulations, standards, and guidelines