Responsable Validation Si H/F

Tailor Your Resume for this Job

Overview
We are a MedTech company located in Sophia Antipolis (Vallauris), in the south of France. In Vallauris (Sophia Antipolis), in th e south of France, we specialize in the production of active implantable class III implans and soon also worldwide distribution of the company's full product portfolio. In addition, the site hosts an R&D team and the sales organization for France.

Would you like to contribute to improving the quality of people with hearing loss?

If so, we could offer you an exciting career at our site in Sophia Antipolis, ITSA Medical on a permanent contract. The bone conduction solutions produced and developed by ITSA Medical are marketed by our sister company Oticon Medical AB. To this end, we develop implantable medical devices and surgical techniques. The Sophia Antipolis site specializes in the production of transcutaneous implants, product development and commercial activities for France. You will be part of the IT team spread across three sites: Sophia Antipolis (Vallauris, France), Gothenburg (Sweden) and Copenhagen (Denmark). The position is based at our main IT hub in Sophia Antipolis. Reporting to the Global IT Director, your main mission will be to is to ensure that all computerized systems used in GxP environments (e.g., production, quality, laboratories) are validated in compliance with international regulatory standards.

Responsibilities

• Implement the strategy & process for the validation of information systems
• Ensure the proper application of applicable regulatory guidelines and the software project methodology presented in GAMP 5
• Responsible of validation process (maintenance and update, and execution
• Coordinate & manage the implementation of validation projects, and ensures support to key stakeholders when appropriate.
• Collaborate with cross-functional teams:Quality Assurance, Production, and external vendors Execute tests of IQ, OQ, PQ protocols if needed; document anomalies, coordinate & manage their resolution.
• Conduct training/awareness on internal validation procedures.
• Contribute to audits of notified bodies and inspections by health authorities.
• Manage periodic reviews, requalification, and change control processes

Requirements

• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and ISO 13485
• Expected qualities: Leadership, rigor, strong communication skills, organization, open-mindedness, team spirit, and autonomy.
• Writing technical and regulatory documents
• Maîtrise des outils de gestion documentaire et de traçabilité
• Excellent communication and project management skills
• Ability to lead cross-functional teams and countries and drive compliance initiatives

Required skills:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• A certification in validation or quality is an advantage
• Mastery of written and spoken professional English

- CDI / 39 heures par semaine

- Horaires flexibles

- Télétravail ponctuel possible

- Type d'emploi : CDI

- Statut : Cadre

Job Type: Full-time
Status: Cadre

Pay: 37,205.09€ - 86,599.86€ per year

Work Location: In person