Job Summary: Support quality engineering initiatives across supplier quality, manufacturing, and quality systems. Ensure products meet regulatory, customer, and internal quality requirements through effective process controls, CAPA execu...
solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including...
Job Summary: The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards such as 21 CFR P...
Responsibilities: Design, budget, implement, and optimize new and existing manufacturing processes to maintain equipment and systems for optimal performance and compliance. Analyze production yields and workflows to identify bottlenecks,...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Roles & Responsibilities: 5+years experience. US Project management experience. Preferable with experiences on Medical devices: Operations, Manufacturing, Supply chain experiences (diverse profiles to be chosen from). Ideal candi...
Responsibilities: Lead end-to-end program strategy, planning, and execution. Manage client relationships and drive business development. Ensure operational excellence and financial oversight. Mentor and manage cross-functional engineer...
Job Description: We are looking for a Project Manager with a strong understanding or prior experience in Packaging Technology to lead projects focused on cost savings, sustenance, and Value Engineering / Value Analysis (VE/VA). This role c...
Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user acces...