Site Quality Head

Rahmendaten

<p><strong>Rahmendaten</strong>: </p> <ul> <li>Laufzeit: 6-9 Monate <li>Auslastung: 40 H/Woche  <li>Einsatzort: <strong>remote möglich</strong> <li>Starttermin: <strong>01.04.2024</strong> <li>Spätester Starttermin: 15.04.2024 </ul> <p><br> <strong>Aufgaben</strong></p> <ul> <li>Generate and manage monthly and weekly reports, ensuring accuracy and timeliness. <li>Develop and implement KPIs for the manufacturing site, monitoring them regularly to ensure effectiveness without compromising compliance. <li>Ensure all activities and actions are completed on time, addressing any deviations promptly. <li>Conduct in-depth analysis of deviations from KPIs, including classification using methods such as Pareto analysis. <li>Prepare necessary actions for compliance with FDA regulations. <li>Provide support for quality management system (QMS) projects, including deviations and corrective and preventive actions (CAPAs). <li>Collaborate closely with the Director of Quality to oversee and manage the site's quality processes. <li>Assist in the development and implementation of the Quality Department strategy to ensure it meets business and compliance requirements, customer requirements and ensures department performance against targets.  <li>- Establish, implement and monitor all quality control and quality assurance systems to ensure compliance with relevant EU directives and FDA regulations and current GMP requirements.  </ul> <strong>Qualifikation</strong> <ul> <li>Previous experience working with manufacturing sites that are FDA approved. <li>Strong knowledge of Good Manufacturing Practices (GMP). <li>Excellent communication skills, with fluency in both German and English. <li>Hands-on mentality with practical experience at the site level. <li>Ability to work independently and as part of a team, demonstrating initiative and problem-solving skills. </ul>