**Job Overview:**
This role is an exciting opportunity to support innovative projects and contribute to the enhancement of product quality and compliance.
We offer flexibility with a choice between permanent employment or a subcontract arrangement, catering to the right candidate's needs.
* Key Responsibilities:
* Develop and execute validation protocols and reports for new products and revalidations, ensuring compliance and effectiveness.
* Promote continuous improvement through Lean Six Sigma methodologies and drive quality standards aligned with ISO 13485 and ISO 14001.
* Lead cross-functional teams, collaborating with vendors on critical projects and ensuring seamless execution.
* Conduct thorough risk assessments and root cause analyses, implementing corrective actions via efficient change management processes.
* Oversee the review and execution of FAT and SAT protocols, guaranteeing adherence to regulations.
* Support GMP and regulatory audits, providing expertise and guidance to stakeholders.
* Deliver comprehensive training and mentorship to colleagues, strengthening validation knowledge across the business.
* Perform in-depth data analysis to inform strategic decision-making and drive process improvements.