About the job
Located in Dreux (28), the Norgine Pharma production site is a recognized international player in the pharmaceutical industry, dedicated to enhancing patients' lives through innovation, industrial excellence, and the expertise of its teams. Currently thriving, the Dreux site is looking for future talents to build the future together!
Joining Norgine Pharma means growing in a human-sized environment that values commitment and responsibility (Drive), encourages audacity and innovation (Dare), and invests sustainably in the development of its employees (Develop).
MISSION:
To implement the global validation strategy at the Dreux site for processes, equipment, utilities, cleaning, and computer systems. Adhere to and comply with Norgine's quality and compliance policies.
KEY ACTIVITIES AND RESPONSIBILITIES:
• Develop the validation and metrology Master Plans for the site.
• Ensure the implementation of Master Plans by verifying that all processes, equipment, utilities, cleaning, and computer systems on site are properly validated and qualified in accordance with current regulations.
MAIN TASKS:
• Establish, implement, or ensure the execution of Validation and Metrology Master Plans.
• Lead and manage personnel under their responsibility.
• Manage, coordinate, plan, supervise, or implement validation/qualification and metrology activities as necessary.
• Provide support to site teams by offering the necessary expertise for the effective execution of operations and adherence to current standards.
• Collaborate with the IT department to ensure that computer validations are performed.
• Work with MSAT and Pharmaceutical Development departments to ensure that process validations are completed.
• Facilitate and participate in cross-functional working groups.
• Ensure risk analysis is implemented in the execution of these activities.
• Review and approve all validation, qualification, and metrology protocols and reports.
• Support the maintenance of the “validated” status for equipment and systems. Provide necessary support to teams.
• Identify gaps and non-conformities, and propose, contribute to the implementation of corrective actions.
• Evaluate and ensure the periodic review of the “validated” status of equipment and systems.
• Monitor regulatory changes and provide necessary training to site teams.
OTHER ACTIVITIES:
• Participate in the implementation of the internal and external audit program.
• Engage in various site projects, whether local or global quality initiatives.
