Roles & Responsibilities: Right now, the CSV team is focused on UATs, periodic review, test scripts and change controls for their Medidata CTMS and IT ServiceNow Infrastructure projects. The focus is to have CSV support the ongoing CTMS....
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...
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...
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: 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...
Responsibilities: 1. Testing and Validation: Plan and conduct functional tests and performance evaluations on hardware prototypes. Identify and troubleshoot issues related to hardware functionality and compatibility. Collaborate with so...
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,...
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...
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: specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including faci...