Chef De Projet Vsi

Galderma Project Manager

Avec un héritage unique en dermatologie ainsi que des décennies d'innovation de pointe, Galderma est le leader émergent de sa catégorie dédié entièrement à la dermatologie, présent dans environ 90 pays. Nous proposons un portefeuille innovant, basé sur la science, de marques phares haut de gamme et de services qui couvrent l'ensemble du spectre du marché de la dermatologie en pleine croissance grâce à l'esthétique injectable, les soins dermo-cosmétiques et la dermatologie thérapeutique.

Depuis notre création en 1981, nous avons consacré notre attention et notre passion à l'organe le plus grand du corps humain - la peau - en répondant aux besoins individuels des consommateurs et des patients avec des résultats supérieurs, en partenariat avec les professionnels de la santé. Parce que nous savons que notre peau façonne l'histoire de notre vie, nous faisons progresser la dermatologie pour chaque histoire de peau.

Location:

Alby-sur-Chéran Contract Type:
Permanent

Your mission:

Report to the Qualification Manager, you will act as the project manager for VSI and as the reference for the lifecycle of computerized systems at the site, in laboratory, manufacturing, and packaging environments.

Your role is primarily project-oriented: you will coordinate the different stakeholders, structure the validation strategy, secure deliverables, and ensure the compliance of computerized systems with regulatory requirements, internal procedures, and Data Integrity principles.

You will work in a demanding and stimulating environment, with numerous projects, multiple interfaces (AQ, IT, OT, Lab, equipment support teams, global VSI team), and a strong exposure to audits and inspections.

Your main responsibilities:

Lead the validation projects of computerized systems

• Coordinate the installation, update, migration, and decommissioning projects of the site's computerized systems.
• Facilitate exchanges between Quality, IT, OT, Laboratory, Production, users, and suppliers teams.
• Build and lead the validation strategy based on a risk-based V-model approach.
• Ensure project progress and completeness of expected deliverables.

Ensure end-to-end validation

• Produce, review, validate, and coordinate deliverables associated with projects: supplier qualification, risk analyses, URS, specifications, validation plans, protocols, reports, traceability matrices.
• Prepare, supervise, or execute tests according to the project's scope.
• Open and follow up on deviations, coordinate investigations, propose action plans, and ensure CAPA follow-up.
• Ensure compliance with deadlines, GMP requirements, and internal procedures.

Contribute to compliance and continuous improvement

• Participate in the compliance of computerized systems with Data Integrity requirements.
• Identify gaps, propose remediation plans, and support their implementation.
• Ensure continuous compliance monitoring of VSI at the site.

Maintain the validated state of operational systems

• Plan and perform, or supervise, periodic reviews of computerized systems.
• Lead or support the management of changes to operational systems.
• Participate in the quality impact assessment of changes and define the appropriate implementation strategy.
• Report and follow up on non-conformities observed in operation, as well as associated CAPAs.

Train and support teams

• Raise awareness among users and process owners of the essential SI validation requirements.
• Support teams in applying GMP and Data Integrity best practices.
• Supervise, if necessary, interns and consultants.

Participate in audits and inspections

• Contribute to the preparation and conduct of client audits and authority inspections.
• Act as the VSI/SME reference in your area.
• Participate, if necessary, in the evaluation or audit of computerized systems suppliers.

Your profile:

• Degree of Bachelor+5, Engineer or Master in Sciences, Technologies or equivalent.
• Minimum 5 years of experience in the validation of computerized systems in the pharmaceutical industry or medical devices. Or significant experience in computerized systems in these sectors, with a strong quality culture and good mastery of applicable…