Sr QA officer (injectable products) - Orléans
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.
Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.
Main Responsibilities:
- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)
- Communicating tasks to the project manager daily and via monthly KPIs.
- Tasks and deliverables for the project and authorities:
• Risk analyses (initiation, execution, conclusion, action plan)
• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)
• GAP analysis against GMP
• Scientific justification (documents) for deviations from regulatory requirements
• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results
• Drafting the CCS DP
Requirements
About You