The Quality Systems Specialist is responsible for maintaining and continuous improvement of the Quality Management System throughout their knowledge and areas of expertise. Ensure that objectives are effectively achieved, consistent with MSD’s requirements to ensure compliance, safety and reliable supply to our customers.
• Provide quality support to the project and site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
• The main areas of expertise are, but not limited to, specific tasks and roles such as: deviation management, change control management, quality systems management, document / SOP management, GMP training & knowledge management.
• Ensure the health & well being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs
• Serve as support for metrics management for site deviation management and change control systems.
• Support the review and approval of site deviation and investigations reports.
• Support the site change management process.
• Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Day to day management of Deviation CAPA and Change Control metrics
• Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
• Liaise directly with cross-functional departments to ensure that change control and deviation management system requirements are met
• Support Regulatory and Compliance Inspections at the site as required
• Support for management of recalls as required
• Comply with Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Build a Quality culture that delivers unconstrained supply, Right First Time to our patients.
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Apply For This JobTo apply for this job email your details to rachael.kennedy@theaphexgroup.com.
To apply for this job email your details to rachael.kennedy@theaphexgroup.com.