Job Description
Our company is a world leader in animal health, offering a wide and innovative portfolio of veterinary medicines and health solutions for all animal species.
Reporting to the IT/OT Manager, your main mission will be to act as the Compliance and Validation referent for Computerized Systems at the Igoville site.
MAIN ACTIVITIES
Compliance and Validation expert role:
•Is the main point of contact for the site (including the Quality Assurance department) and suppliers regarding their area of expertise
•Defines the site's standards for Computerized Systems Validation in line with regulations and recommendations
•Presents the validation strategy and associated documents during Audits and Inspections
•Provides support to Technical Experts to validate Computerized Systems and maintain this validated state throughout the system's lifecycle
•Trains technical experts to ensure their good understanding of current regulations
•Provides recommendations on the retirement of obsolete systems and on the retention period of archived data
•Participates in retirement and archiving activities to verify compliance with current regulations
Routine support:
•Privileged partner of production and laboratory sectors
•Participates in technical and documentary investigations
•Plays the role of Technical expert for certain systems (including validated Excel files)
•Participates in investigations in case of incident and/or deviation
•Carries out annual maintenance activities as well as periodic review of computerized systems
•Takes charge of routine actions (access management, Data Integrity…)
Documentation System and Change Management:
•Ensures that the department's documents are up to date
•Proposes and carries out modifications (organization, simplification) of the documentation system for the department
•Evolves the department's documents according to the evolution of Group policies and procedures
•Provides support and/or takes charge of the organization and documentation required during modifications of Computerized Systems
Contributes to project success:
•Works closely with Project Managers to define the Validation Strategy associated with the implementation of the new system
•Supports Project Managers in drafting documents related to system validation
•Participates in and carries out validation steps within the project
Innovates and is a source of proposals:
•Identifies and leads improvement actions to optimize validation activities
•Proposes innovative developments in their area of expertise while respecting current regulations
PROFILE
Education:
•Bachelor's degree (Bac+3), Engineering degree, or Master's degree (Bac+5) in a technical, pharmaceutical, or quality field
Experience:
•At least 3 years of experience in the pharmaceutical industrial environment
Skills:
•Knowledge of GAMP5, GMP (Good Manufacturing Practices) and 21CFR Part 11
•Knowledge of Data Integrity rules
•Good command of Excel and office tools
•Basic project management knowledge
•Professional English (technical and conversational)
•Need to communicate with Group contacts and inspectors, other sites, suppliers
Soft skills:
•Customer-oriented and problem-solving: ability to support the site's industrial performance
•Analytical skills and pragmatism: propose solutions adapted to client needs
•Proactive: be innovative in implementing new solutions
•Rigor and autonomy at work
•Ability to work as a team and with other departments (Projects, Maintenance, Quality Assurance) and Group contacts
•Easy communication and interpersonal skills with all stakeholders: ability to explain the advantages/disadvantages of several options and be persuasive
Required Skills: Compliance Activities, Control Monitoring, Data Integrity, Data Validation, Excel Reports, Information Security, IT Risk Governance, Knowledge of regulations and frameworks, Legacy Systems, Project Management Methodology (PMM), Quality Management, Regulatory Frameworks, System Audits
Flexible Work Arrangements: Hybrid
